>> EVERYONE PLEASE TAKE THEIR SEATS PLEASE SO WE CAN START THE MEETING. SO GOOD MORNING, I'M NANCY DVDSON, CHAIR OF CTAC. WELCOME TO OUR 34th MEETING. I WANT TO START BY READING THE OPENING STATEMENT WHICH I THINK YOU'RE FAMILIAR. AS COMMITTEE MEMBERS I WANT TO REMIND YOU THAT YOU MUST ABSENT YOURSELVES DURING SPECIFIC DISCUSSIONS WHENEVER YOUR PARTICIPATION DELIBERATIONS ON A PARTICULAR PRODUCT PROGRAM OR OTHER SPECIFIC MATTER WOULD CONSTITUTE A CONFLICT OF INTEREST OR CREATE THE APPEARANCE OF ONE. IT IS INCUMBENT UPON YOU TO ADVISE THE EXECUTIVE SECRETARY AND ABSTAIN FROM PARTICIPATION AND DISCUSSION OR ACTS REGARD, THAT MATTER. IN LIGHT OF CURRENT POLICIES GOVERNING CONFLICT OF INTEREST BASED ON FINANCIAL HOLDINGS OF GOVERNMENT PLOY EYES INCLUDING THIS COMMITTEE, WE DEPEND ON YOU TO ABSENT YOURSELF DURING ANY AND ALL DISCUSSIONS OF MATTERS THAT CONCEIVABLY IMPACT THE STATUS OF HOLDINGS. WE TRUST YOUR JUDGMENTS IN THESE INSTANCE. BY LAW A QUORUM OF BOARD MEMBERS IS REQUIRED FOR EACH INSTANCE WHICH A VOTE OCCURS IN OPEN SESSION. DURING THIS MEETING TEN APPOINTED MEMBERS WILL BE PRESENT TO VOICE VOTES. NEW MEMBERS NOT CURRENT MEMBERS OF ANOTHER NCI ADVISORY BOARD ARE NOT VOTING UNTIL THEY HAVE BEEN CLEARED BY NCI EVIDENCICS ETHICS OFFICE AND HUMAN RESOURCES. I ALSO WANT TO READ THE PUBLIC COMMENT STATEMENT, MEMBERS OF THE PUBLIC MAY WISH TO EXPRESS VIEWS REGARDING ANY ITEMS DISCUSSED DURING THIS MEETING MAY DO SO BY WRITING DR. SHEILA PRINDIVILLE WITHIN TEN DAYS OF THE MEETING. WRITTEN STATEMENTS BY MEMBERS OF PUBLIC RECEIVE CAREFUL CONSIDERATION. FINALLY THIS MEETING IS BEING BROADCAST AND CURRENTLY AVAILABLE ON THE NIH VIDEOCAST WEBSITE, THE BROADCAST WILL BE ARCHIEED FOR VIEWING LATER. SO WITH ALL THAT, WELCOME. OUR NEUROMEETING DATES ARE IN YOUR AGENDA, PUT THEM ON YOUR CALENDAR. I HAVE ONE ACTION ITEM. I WOULD LOVE TO PUT OUT A MOTION TO ACCEPT THE MINUTES FROM JULY 12th, 2017 MEETING. SECOND. ALL IN FAVOR. IN THINK OPPOSED? THANK YOU VERY MUCH. THIS IS EARLY SPECIAL MEETING FOR US BECAUSE WE HAVE THE OPPORTUNITY TO WELCOME THE NEW NATIONAL CANCER INSTITUTE DIRECTOR NED SHARPLESS SEATED TO MY LEFT. SO I WANT TO OPEN THE MEETING BY GIVING NED A CHANCE TO SAY A WORD OR TWO WITH US. >> THANK YOU. I'M GLAD TO BE HERE AFTER SOMEWHAT LENGTHY SWEARING IN PROCESS I'M TOLD MANY OF YOU ABOUT. GOOD TO SEE FRIENDS AND FACES I LOOK FORWARD TO MEETING. I'M EXCITED ABOUT TAKING ON THE NEW ROLE. RIGHT NOW I'M IN A LISTENING MODE GOING AROUND TO MEETINGS TRYING TO FIGURE OUT WHAT THE NCI DOES BECAUSE IT'S ENORMOUS. IF YOU THINK I HAVE ALSO DISCOVERED ABOUT THE NCI SINCE I STARRED IS WONDERFUL, IT'S POCKETS OF UNBELIEVABLE EXCELLENCE THAT ARE JUST DIVERSE AND GREAT. AND I THINK THE MISSION OF THIS BOARD IS PARTICULARLY IMPORTANT TO ME, CLINICAL TRIALS IS SOMETHING I THINK THE -- IS CANCER CENTER DIRECTOR I LOVE THE CHALLENGE OF RUNNING CLINICAL TRIALS ORGANIZATION FOR MANY YEARS AND I KNOW THAT THE NATURE OF CLINICAL TRIALS ONCOLOGY CHANGED DRAMATICALLY OVER THE LAST DECADE AND KEEPING UP WITH THAT IS A REAL CHALLENGE FOR NCI SO I APPRECIATE THE WORK OF THE BOARD AND LOOK FORWARD TO LEARNING MORE. LASTLY THANK YOU FOR DOING THIS. I KNOW THE BOARDS ARE A LOT OF WORK. I KNOW THIS IS A LOT OF TIME AND IN SOME WAYS A THANKLESS TASK SO I APPRECIATE COMING HERE AND SERVING THE NCI IN THIS CAPACITY. THANK YOU ONCE AGAIN. LASTLY, I'M GOING TO APOLOGIZE BECAUSE I'M GOING TO BE IN AND OUT AND THEN I HAVE A NIGHT TO CATCH AT NOON SO I WON'T STAY LONG BUT I DO PROMISE TO COME BACK AND ON A DAY WHEN I ACTUALLY CAN PARTICIPATE TO MORE COMPLETE DEGREE. THANK YOU. >> WELCOME, NED. CONGRATULATIONS. WE LOOK FORWARD TO WORKING WITH YOU. SO WE HAVE A REALLY ACTIVE AGENDA FOR THE MORNING THAT HAS TO DO WITH SEVERAL WORKING GROUP REPORTS THAT ARE COMING OUT, SOME DISCUSSION ABOUT THE VA AND THEN THE N CORP DISCUSSION. SO WE'LL START WITH THE PRESENTATION THAT WE PROMISED LAST JULY FROM THE CLINICAL TRIALS INFORMATICS WORKING GROUP REPORT. YOU REMEMBER THIS GROUP WHICH IS CHAIRED BY KIBBE WAS FORMED IN 2015. THE GOAL WAS TO PROVIDE EXPERTISE AND ADVICE ON IMPLEMENTATION OF NCI CLINICAL TRIALS INFORMATICS INITIATIVES. OUR DISCUSSION TODAY IS LED BY DR. SAROSI, MEDICAL OFFICER LEAD FOR CLINICAL TRIALS INFORMATICS AND COORDINATING CENTER OF THE CLINICAL TRIALS AT THE NCI AND ALSO BY HENRY CIOLINO, DIRECTOR OF OFFICE OF CANCER CENTERS. THEY WILL GIVE BACKGROUND ABOUT THE CLINICAL TRIALS REPORTING PROGRAM, HOW THE DATABASE HOW THE NCI USES THAT INFORMATION, AND THEN LOU AND WARREN WILL PRESENT THE REPORT WHICH INCLUDES 24 RECOMMENDATIONS TO THE ADVISE THE NCI AND REFINING THE CLINICAL TRIALS REPORTING PROGRAM. AS A WAY OF TRYING TO MANAGE THE CLINICAL TRIALS PORTFOLIO AND RESOURCE. AND I WANT TO REMIND YOU THIS IS AN ACTION ITEM FOR US AT THE END OF THIS PARTICULAR DISCUSSION WE WILL BE LOOKING FOR A VOTE TO ACCEPT THE REPORT AND THE RECOMMENDATIONS. SO WITH THAT, MAYBE I CAN LET DR. SAROSI GET STARTED. LOOKS LIKE LOU IS GOING TO START OFF. >> THIS WILL BE A TAG TEAM PRESENTATION. GOOD MORNING. WE'RE PLEASED TO PRESENT THIS REPORT. THE CLINICAL TRIALS INFORMATICS WORKING GROUP. I'M JUST GOING TO LEAD OFF AND THEN I WILL BE FOLLOWED BY HENRY, COME BACK AND THEN WARREN AND THEN WARREN AND I WILL COME BACK AND CHAT A BIT ADS WELL. THE BACKGROUND OF THIS TO REMIND EVERYBODY, IS THAT WE -- THOSE OF US IN THE CANCER CENTER MOVEMENT HAVE LONG BEEN REQUIRED TO SUBMIT A DATA TABLE AS PART OF CCSG COMPETITIVE RENEWALS. THE CLINICAL TRIALS WORKING GROUP WAS FORMED TO THINK ABOUT WAYS TO USE CTRP MORE EFFECTIVELY AS WE MOVE FORWARD. HIGHLIGHTS INCLUDE HOW TO IMPROVE ACCESS TO CTRP DATA, WHAT CIRCUMSTANCES SHOULD WE EXPAND CTRP DATA, HOW TO IMPROVE CLINICAL TRIALS SEARCHING, HOW TO RECORD ACCRUALS TO PRECISION MEDICINE TRIALS AND HOW TO IMPLEMENT CTRP GENERATED DATA TABLE FOR INTERVENTIONAL TRIALS& AND AFTER THAT WE'LL HAVE A DISCUSSION AND THEN MOVE FOR APPROVAL OF OUR REPORT. WITH THAT I'M GOING TO TURN IT OVER TO JOY SEVERAL WHO WILL GIVE YOU BACKGROUND INTO THE CTRP PROGRAM. THANK YOU. >> THANK YOU. WHAT IS CTRP? CTRP IS A COMPREHENSIVE DATABASE CONTAINING REGULARLY UPDATED INFORMATION INCLUDING ACCRUAL ON ALL NCI SUPPORTED INTERVENTIONAL CLINICAL TRIALS. IT UTILIZES STANDARDIZED DATA ELEMENTS AND CONSISTENT PROTOCOL ABSTRACTION, IT SUPPORTS NCI CLINICAL TRIALS PORTFOLIO MANAGEMENT BY IDENTIFYING GAPS IN THE PORTFOLIO AND PRIORITIZING CLINICAL RESEARCH OPPORTUNITIES. IT SUPPORTS REGISTRATION AND RESULTS REPORTING TO CLINICAL CLINICALTRIALS.GOV FOR NCI SPONSORED TRIALS AND COMPLIANCE WITH NIH POLICIES AND LEGISLATION. RATIONALE FOR DEVELOPMENT, KEY CONCLUSIONS OF THE 2005 CLINICAL TRIALS WORKING GROUP REPORT AND 2010 INSTITUTE OF MEDICINE REPORT INDICATED THAT NCI HAD NO ELECTRONIC DATABASE THAT CAPTURED ALL NCI SUPPORTED CLINICAL TRIALS AND THEIR ACCRUAL. TRIAL SUPPORTED BY GRANTS SUCH AS RO1s, R-21s, PO 1s, ET CETERA, INSTITUTIONALLY SUPPORTED TRIALS USING NCI FUNDED CANCER CENTER INFRASTRUCTURE RESOURCES WERE PARTICULARLY DIFFICULT TO IDENTIFY. AVAILABLE DATABASES DIDN'T ALLOW NCI AND THE BROADER CANCER COMMUNITY TO MONITOR ACCRUAL, IDENTIFY GAPS AND DUPLICATIVE STUDIES AND EFFECTIVELY PRIORITIZE CLINICAL TRIALS. KEY ATTRIBUTES OF CTRP ONE EXISTING DATABASES FOR EXAMPLE CLINICAL TRIALS.GOV, DO NOT FULFILL ALL PURPOSES AND VISION FOR NCI DATABASE. CTRP ADDRESSES THESE GAPS THROUGH THE FOLLOWING. CONSISTENT TERM NOL AND STANDARDIZED DATA ELEMENTS TO OPTIMIZE SEARCH AND RETRIEVAL OF CANCER CLINICAL TRIALS INFORMATION, INCLUSION OF STRUCTURED BIOMARKER INFORMATION QUARTERLY REPORTING OF ACCRUAL INCLUDING DEMOGRAPHY, STANDARD REPRESENTATION OF PERSONS AND ORGANIZATIONS, IDENTIFICATION OF ASSOCIATED NCI AWARDS AND CLINICAL TRIALS AND REGULAR UPDATES TO REFLECT PROTOCOL AMENDMENTS AS WELL AS PARTICIPATING SITE AND STATUS CHANGES. THE SCOPE AND CONTENT OF CTRP INCLUDES NCI SUPPORTED INTERVENTIONAL CLINICAL TRIALS. AND THESE ARE TRIALS TAKING PLACE IN AT LEAST ONE NCI DESIGNATED CANCER CENTER INCLUDING INDUSTRIAL TRIALS. TRIALS SPONSORED BY NCI AS WELL AS TRIALS SPONSORED BY OTHER ENTITIES. CTRP SUPPORTS BUT DOES NOT REQUIRE REGISTRATION OF NON-INTERVENTIONAL STUDIES, FOR EXAMPLE THOSE THAT ARE OBSERVATIONAL WERE ANCILLARY CORRELATIVE. ACCRUAL DATA IS REPORTED FOR ALL ACTIVE TRIALS QUARTERLY. PARTICIPANT LEVEL DATA FOR ALL EXCEPT IN INDUSTRIAL TRIALS WHICH CUMULATIVE DATA IE ACCRUAL TO DATE IS REPORTED. THE FOLLOWING TWO SLIDES ARE AN OVERVIEW OF CTRP WORK FLOW, THE FIRST IS TRIAL REGISTRATION, AMENDMENTS AND UPDATES. NATIONAL TRIALS ARE REGISTERED IN CTRP BY BEING TRANSFERRED WITHIN NCI FROM NCI CTEP AND DCP DATABASES. THE EXTERNALLY PEER RERUE AND INSTITUTIONAL TRIALS ARE ENTERED INTO CTRP DIRECTLY BY THE NCI AWARDEES SUCH AS NCI DESIGNATED CANCER CENTER AND THE LEAD ORGANIZATION IS RESPONSIBLE FOR REGISTERING A TRIAL FOR MULTI-INSTITUTIONAL TRIALS. THESE ARE SUBMITTED TO THE CLINICAL TRIALS REPORTING OFFICE WHICH ARE THE ABSTRACTERS WHO PUT THE DATA INTO CTRP. FOR INDUSTRIAL TRIALS WHICH WE DO NOT REQUIRE A PROTOCOL, THESE TRIALS ARE IMPORTED INTO CTRP FROM CLINICALTRIALS.GOV BY CANCER CENTER REQUESTS. I SHOULD ALSO NOTE THAT CCR DATA ARE TRANSFERRED WITHIN NCI NOT REQUIRING ANY ADDITIONAL INPUT BY THE NCI AWARDEE. THERE'S A SIMILAR WORK FLOW FOR ACCRUAL DATA SIMILARLY ACCRUAL FOR NATIONAL TRIALS, PARTICIPANT LEVEL DATA IS TRANSFERRED DIRECTLY TO CTRP FROM CTEP DCP DATABASES. EXTERNALLY PEER REVIEWED AND INSTITUTIONAL PARTICIPANT LEVEL DATA ARE ENTERED DIRECTLY INTO CTRP BY THE NCI AWARDEE. AND CUMULATIVE DATA, CUMULATIVE COUNT ONLY ARE REPORTED TO CTRP BY EACH PARTICIPATING SITE. THIS SLIDE GIVES OVERVIEW OF INTERVENTIONAL CLINICAL TRIALS REGISTERED IN CTRP AS OF SEPTEMBER 2017. THIS IS A SNAP SHOT OF ALL CLINICAL TRIALS THAT WERE OPEN TO PATIENT ACCRUAL ON OR AFTER JANUARY 1st, 2013 WHEN ACCRUAL REPORTING TO CTRP BECAME REQUIRED. I SHOULD NOTE THIS INCLUDE BOTH TRIALS CURRENTLY OPEN OR TRIALS THAT CLOSED SINCE JANUARY 21st, 2013. THIS INCLUDES APPROXIMATELY 12,000 INTERVENTIONAL CLINICAL TRIALS AND AS YOU CAN SEE IN THE RED SECTION OF THE GRAPH, VIRTUALLY THE VAST MAJORITY OF TREATMENT TRIALS. IF ONE LOOKS AT THE RIGHT SIDE OF THE SLIDE, THIS INDICATES THE ACCRUAL REPORTED TO CTRP AND AS OF SEPTEMBER 2013 AMONG THESE ALMOST 12,000 TRIALS, 600,000 ACCRUALS ARE REPORTED TO CTRP WHICH APPROXIMATELY 75% ARE PARTICIPANT LEVEL OR THOSE RECORDS WHICH INCLUDE DEMOGRAPHIC INFORMATION. SO WITH THAT I WOULD LIKE TO TURN TO DR. HENRY CIOLINO, DIRECTOR OF KAREN CENTERS. >> DO YOU WANT QUESTIONS NOW OR AT THE END? WHAT'S YOUR PRESENCE? >> I THINK AT THE END. THANK YOU, AND GOOD MORNING, EVERYONE. ONE OF THE RECOMMENDATIONS THAT YOU'RE GOING TO BE CONSIDERING LATER TODAY IS TO REPLACE DATA TABLE 4 WITH CTRP GENERATED REPORT. SO WE WANT TO MAKE SURE EVERYONE UNDERSTOOD WHAT DATA TABLE FOUR IS. THIS IS SUBMITTED AS PART OF THE CANCER CENTERS SUPPORT GRANT APPLICATION. IT IS THE ONLY COMPLETE SUMMARY OF CANCER CENTERS CLINICAL TRIALS PORTFOLIO THAT NCI RECEIVES. NATIONAL TRIALS GO TO CTEP. THIS ALSO REPORTS ALL THE INDUSTRIAL INSTITUTIONAL AND EXTERNALLY PEER REVIEWED CLINICAL TRIALS. IT ALSO CONTAINS ACCRUAL DATA. THIS COMES IN WITH EACH NON-COMPETING AND COMPETING APPLICATION. IN THE COMPETING APPLICATION IT'S USED BY REVIEWERS TO ASSESS CLINICAL TRIALS ACTIVITY. IN THE NON-COMPETING APPLICATIONS, THEORETICALLY IT SUPPORTS PORTFOLIO ANALYSIS. IF YOU CAN IMAGINE TRYING TO ANALYZE PORTFOLIO WITH 62 SEPARATE XL SPREADSHEETS OPEN ON YOUR COMPUTER YOU CAN UNDERSTAND WHY WE HAVE DONE VERY LITTLE PORTFOLIO ANALYSIS. THIS IS AN EXAMPLE, IT'S FOUR SEPARATE TABLES FOR EACH TYPE OF TRIAL NATIONAL INSTITUTIONAL EXTERNALLY PEER REVIEWED TRIALS ALL WITH DATA ELEMENTS CAPTURED IN CTRP. THE REASON TO SUBSTITUTE A CTRP GENERATED REPORT IS BECAUSE WE DON'T WANT TO INCREASE THE BURDEN OF THE APPLICATION ON OUR CANCER CENTERS. WHY HAVE DUPLICATE REPORTING. IT CAN ASSURE CONSISTENCY AS PARTICULARLY IN TRIAL CHARACTERISTICS OF MULTI-SITE TRIALS MAKING SURE EVERYTHING IS REPORTED THE SAME WAY. BY EACH CENTER. IT CAN IMPROVE ACCURACY. WE DON'T HAVE ANY CONCERNS ABOUT DUPLICATE REPORTING OF ACCRUAL USING CTRP. OF COURSE AS YOU WILL HEAR FROM THE CO-CHAIRS OF THE WORKING GROUP, IT WILL SUPPORT PORTFOLIO ANALYSIS REALLY FOR THE FIRST TIME. OVER THE LAST TWO TO THREE YEARS THE OFFICE OF CANCER CENTERS HAS BEEN MEETING WITH GISELLE AND SHEILA PRINDIVILLE AND TEAM TO RECONCILE DATA TABLE FULL REPORTS WITH WHAT THEY SAW IN CTRP. AND ALSO THE CTRP TEAM HAS BEEN IMPROVING THE SYSTEM CONSTANTLY. AND CENTERS NOW HAVE THE ABILITY TO GENERATE THEIR OWN CTRP REPORTS. I WILL NOW TURN IT OVER TO WARREN WHO WILL GIVE US THE WORKING GROUP RECOMMENDATIONS. >> THANK YOU, HENRY. AS YOU HEARD, THIS IS A CULMINATION OF TWO YEARS OF EFFORT, AND TO PARAPHRASE DR. DOROSHOW DIDN'T THINK WOULD TAKE THAT LONG. IT'S GREAT TO BE HERE AND GREAT TO GET A CHANCE TO TALK ABOUT THE RECOMMENDATIONS. SO JUST TO REITERATE THE PURPOSE OF THE WORKING GROUP WAS TO PROVIDE EXPERTISE AND ADVICE ON IMPLEMENTING NCI CLINICAL TRIALS, FROM AN INFORMATICS PERSPECTIVE. WITH A GOAL OF IMPROVING THE VALUE OF CLINICAL TRIAL DATA, INCREASING ACCESSIBILITY OF THAT INFORMATION, FOR PHYSICIANS PATIENTS AND THE PUBLIC. MINIMIZE BURDEN OF CANCER CLINICAL TRIALS DATA MANAGEMENT AND THAT'S AGAIN SOMETHING THAT I THINK WE HAVE TAKEN TIME TO DISCUSS AS A WORKING GROUP. AND STREAMLINE CLINICAL TRIAL CONDUCT DATA ANALYSIS AND REPORTING AND THAT'S AGAIN FROM A DATA STANDPOINT NOT FROM ACTUALLY RUNNING A TRIAL. OUR FOCUS UP UNTIL NOW REALLY HAS BEEN THE CLINICAL TRIALS REPORTING PROGRAM. YOU WILL SEE THAT IN OUR RECOMMENDATIONS. SO I WANT TO RECOGNIZE IN ADDITION TO LOU AND MYSELF THE MANY MEMBER OF THE INFORMATICS WORKING GROUP, RODA AT YALE, WALLY ERIN PART OF THE CTAC, STAN GERSON PART OF CTAC. MICHAEL LE BLANK. LYNN MATRISIAN, SERENA MADOFF, GEORGE SLEDGE AND RICHARD SELLERS. AND OUR EXECUTIVE SECRETARY GISELLE SAROSI. THE FOLKS AT NCI WHO HAVE BEEN PROVIDING US WITH THE INFORMATION AT CTRP AND THE CLINICAL TRIALS PORTFOLIO. I WILL MENTION THEM BRIEFLY. JEFF ABRAMS, HENRY CIOLINO, DENICOFF, BRAD HESSEY. TONY CALAVICH, LORI AND SHEILA PRINDIVILLE. WE APPRECIATE THEIR HELP IN PTTING THIS INFORMATION TOGETHER BECAUSE WE COULDN'T HAVE BEEN SUCCESSFUL IN COMING UP WITH RECOMMENDATIONS OTHERWISE. ONE OF THE FIRST THINGS WE DID IS REALIZE A NUMBER OF DIFFERENT SECTIONS TO DIG INTO. AND WE BROKE THE WORKING GROUP INTO TWO SUBGROUPS. ONE FOCUSED ON HOW TO IMPROVE SEARCH AND ACCESSIBILITY OF CLINICAL TRIAL DATA. FOCUS COMING FROM CTRP. AND THEN THE OTHER WAS REALLY FOCUSED ON PERCEIVED INCONSISTENCIES AND AMBIGUITIES IN EXISTING CTRP DATA AND HOW WE RECOMMEND SCOPE OF CTRP BE CHANGED. THAT'S FROM EXPANSION STANDPOINT, NOT REMOVING ANYTHING FROM CTRP. WE HAVE MET NUMEROUS TIMES THE PAST TWO YEARS, AND MOST RECENT LY WE DISCUSSED RATIFIED RECOMMENDATIONS BEFORE YOU. WE ADDRESS A NUMBER OF TOPICS A FEW WHICH ARE UP HERE. AND THE ONES THAT IN PARTICULAR WE WERE VERY FOCUSED ON HOW TO FACILITATE ACCESS TO CTRP DATA. MOVE TOWARDS DATA TABLE FOR COMMUNITY. AND IMPROVE UNDERSTANDING OF VALUE OF CTRP FOR THE WHOLE COMMUNITY. THAT WAS SOMETHING AGAIN THERE WERE A NUMBER OF SURVEYS OF CLINICAL TRIAL COMMUNITY AND WE DISCOVERED TO OUR DISMAY THAT CTRP WAS NOT WELL UNDERSTOOD OR CHARACTERIZED BY MOST PEOPLE IN CANCER CENTERS. SO GOING THROUGH THE HIGHLIGHTS OF THE RECOMMENDATIONS, AGAIN, WE -- THE CURRENTLY, THIS IS THE CURRENT STATUS, DATA TABLE FOR -- ALL THE DATA ARE PUBLIC THAT ARE IN CTRP WITH THESE EXCEPTIONS. DATA TABLE 4 STUDY SOURCE. THAT'S WHETHER OR NOT CLINICAL TRIAL WAS CHARACTERIZED AS NATIONAL EXTERNALLY PEER REVIEWED, INSTITUTIONAL OR INDUSTRIAL. BIOMARKERS NOT PART OF INCLUSION AND EXCLUSION. SO THE BIOMARKERS THAT ARE PART OF INCLUSION EXCLUSION ARE PART OF THE PUBLIC FEE AND ACCRUAL DATA ITSELF. IS NOT PUBLICLY ACCESSIBLE. THE NCI CLINICAL TRIALS SEARCH API AND THAT'S THE API AGAIN, THAT'S THE APPLICATION PROGRAMMING INTERFACE PROVIDES DATA TO ANYONE WHO WANTS TO CONSUME IT IN WHAT I THINK OF AS VERY CONSUMABLE WAY BUT IT DOES REQUIRE COMPUTING EXPERTISE TO BE ABLE TO ACCESS IT AND MAKE SENSE OF IT. IT IS A SOURCE OF CLINICAL TRIALS SEARCHING ON CANCER.GOV AND AVAILABLE TO ANYONE EXTRAMURALLY FOR -- THAT WANTS TO TAKE ADVANTAGE OF THAT FEE. THIS IS AN EXAMPLE OF THE DATA THAT WE'RE RECOMMENDING SHOULD BE MADE PUBLIC. THE PART THAT IS NOT CURRENTLY PUBLIC, YOU CAN SEE THERE IS HOW ALL THE CLINICAL TRIALS ARE CATEGORIZED BY STUDY SOURCE. SO THAT REALLY MEANS, THAT'S THE NATIONAL INSTITUTIONAL EXTERNAL HI PEER REVIEWED INDUSTRIAL TRIALS. CANCER CENTER AVAILABLE BUT NOT CATEGORIZED IN THE CCSG DATA TABLE 4. OUR RECOMMENDATION IS TO MAKE IT PUBLIC SO THAT WOULD DEBLIND THE X AXIS SO RATHER THAN CANCER CENTERS IT WOULD BE NAMED CANCER CENTERS. SO THE SECOND RECOMMENDATION IS THAT WE MAKE BIOMARKER INFORMATION THAT'S CURRENTLY NOT AVAILABLE PUBLIC. BIOMARKER INFORMATION REQUIRED FOR TREATMENT ASSIGNMENT, RESPONSE ASSESSMENT AND STRATIFICATION OF TRIAL RESULTS. WE THINK WITH ALL THE CHANGES HAPPENING IN BIOMARKER AND MOVING MORE INTO PRECISION ONCOLOGY, IT'S VERY IMPORTANT ALL THAT BIOMARKER INFORMATION BE PUBLICLY ACCESSIBLE. THAT WOULD BE ACROSS THE ENTIRE NCI SUPPORTED TRIAL PORTFOLIO. TO GIVE YOU A SENSE HOW MANY TRIALS THAT IS, YOU CAN SEE IN THAT PIE CHART, THERE ARE 1350 PUBLIC TRIALS THAT HAVE BIOMARKERS, 2600 OR SO THAT DON'T CONTAIN BIOMARKERS AS PART OF CRITERIA AND NUMBER OF TRIAL THAT DON'T HAVE PUBLIC INFORMATION SO THEY'RE INDUSTRIAL TRIALS. SO THE OTHER AREA OF RECOMMENDATIONS AROUND ACCRUAL THAT THERE'S AFTER COURSE PARTICIPANT LEVEL ACCRUAL CURRENTLY IN CTRP. THERE'S AGGREGATE ACCRUAL, AND DEMOGRAPHIC DATA AVAILABLE IN CTRP BUT NOT PUBLIC CURRENTLY. OUR RECOMMENDATION PARTICIPANT LEVEL ACCRUAL DATA IS NOT MADE PUBLIC. SOME OF OUR THINKING BEHIND THAT IS NOW WE DO NOT HAVE THE CONSENT AGREEMENTS IN PLACE THAT ENABLE US TO MAKE THAT UNIFORMLY PUBLIC. THERE'S ALSO CONCERN THAT EVEN WHEN DEIDENTIFIED, IT COULD BE IDENTIFIED FOR CERTAIN INDIVIDUALS IN SOME CIRCUMSTANCES WHEN LOOKING AT RARE CANCERS AND RARE LOCATIONS. HOWEVER WE THINK IT'S ALREADY VERY IMPORTANT THAT ACCRUAL DATA BE MADE AVAILABLE TO RESEARCHERS AND THAT WAS A RECOMMENDATION THAT WE MADE AS WELL THAT THERE BE A MECHANISM IN PLACE FOR PEOPLE TO REQUEST ACCESS TO ACCRUAL DATA. THROUGH A APPROPRIATELY VETTED CHANNEL. WE ALSO THINK IT IS IMPORTANT THAT WE ALLOW AGGREGATE ACCRUAL REPORTS BASED ON DISEASE TRIAL PHASE STUDY SOURCE CANCER CENTER ALL THINGS THAT ARE CURRENTLY COMMONLY USED TO SLICE AND KYES ACCRUAL DATA. AND WE THINK THAT INFORMATION AVAILABILITY OF AGGREGATE DATA BE MADE AVAILABLE FOR ACTIVELY ACCRUING NATIONALLY PEER REVIEWED INSTITUTIONAL TRIALS AND INDUSTRIAL TRIALS WOULD BE MADE AVAILABLE AFTER THEY CLOSED AND RESULTS ARE POSTED IN CLINICALTRIALS.GOV. THERE BE A MECHANISM FOR LEAD INVESTIGATORS FOR EXTERNALLY PEER REVIEWED INSTITUTIONAL TRIALS FOR THEM TO REQUEST THAT THEY ONLY POST AILING GRATE RESULTS RATHER THAN -- SORRY, AGGREGATE ACCRUAL RESULTS AFTER STUDY CLOSURE RATHER THAN AS IT'S GOING ON AND THAT'S ARE PRESENT IN THEIR CLINICAL TRIALS WITH SPONSORS. SO JUST TO SHOW YOU WHAT SOME OF THAT, AGAIN THAT AGGREGATE DATA WOULD LET US DO, YOU CAN SEE THAT THIS IS AN ORGANIZED LEFT TO RIGHT BY DECREASING PERCENTAGE OF ACCRUAL ON NATIONAL TRIALS. AGAIN, A POINT I WANT TO MAKE IS THERE'S NO RIGHT ANSWER HERE FOR THAT DISTRIBUTION BUT WHAT IS REALLY REMARKABLE BOTH IN THIS GRAPH AND THE OTHER GRAPH, IS HOW DIFFERENT ALL CANCER CENTERS ARE. AGAIN, THAT'S REALLY IMPORTANT TO RECOGNIZE IS THAT EACH CANCER CENTER HAS A UNIQUE APPROACH TO CLINICAL TRIALS. THAT IS NOT NECESSARILY BAD. IN FACT I ARGUE IT'S A GOOD THING. BUT AGAIN, THIS -- THE WITH THE CAVEAT THIS DOES NOT INCLUDE A REAL TIME INDUSTRIAL TRIAL AGGREGATE DATA THIS WOULD BE MUCH CLOSER TO REAL TIME VIEW OF CANCER CENTERS AND CURRENT ACCRUAL ACROSS THIS CATEGORIZATION OF NATIONAL INSTITUTIONAL EXTERNALLY PEER REVIEWED AND INDUSTRIAL. TO GIVE YOU A SENSE OF HOW MUCH THAT DATA IS, GISELLE MENTIONED THE NUMBERS. SO YOU CAN SEE, LOOKING AT TRIALS BY STUDY SOURCE FOR SINGLE CENTER, THIS PARTICULAR CENTER HAD 334 TRIALS AT THAT POINT IN TIME, BACK IN JULY. THERE WERE ALMOST 4,000 ACCRUALS ON INTERVENTIONAL TRIALS DURING THAT PERIOD OF TIME. YOU CAN SEE THE BREAKDOWNS BY NATIONAL, INSTITUTIONAL INDUSTRIAL AND EXTERNALLY PEER REVIEWED. JUST TO REITERATE THAT AGGREGATE ACCRUAL BY DEMOGRAPHY MADE PUBLIC FOR TRIALS ACCRUAL CLOSE TO ACCRUAL. THAT'S REALLY IMPORTANT FOR A NUMBER OF REASONS. THERE IS A SECOND PAGE. WE ALSO THINK IS IMPORTANT AS PART OF THIS WHEN RELEASING THAT ACCRUAL DATA WE PUT IN PLACE, SOME LIMITS ON RELEASE OF EVEN THE AGGREGATE DATA. SO TRADITIONAL WAY OF THINKING IS WHEN A SIZE IS BELOW A SMALL NUMBER, USUALLY SIX, COULD BE SET DIFFERENTLY THAN THAT, THAT THAT -- THERE'S AN ASTERISK AROUND THAT NUMBER, IT'S NOT ACCURATELY REPORTED WHEN THERE'S A SMALL -- AGAIN, THAT PROTECTS THE INDIVIDUALS INVOLVED IN THAT PARTICULAR BIN. EXPANDING CTRP DATA. CTRP DATA SHOULD COLLECT MINIMAL INFORMATION OBSERVATIONAL STUDIES, DOES NOT CURRENTLY DO THAT. IT SHOULDN'T COLLECT ANCILLARY CORRELATIVE STUDIES AT THE PRESENT TIME. AND SHOULD NOT BE USED TO COLLECT TOXICITY ADVERSE EVENT DATA NOR OUTCOMES DATA. I WILL GO THROUGH THE REASONS FOR THAT VERY BRIEFLY. WE DO THINK OBSERVATIONAL STUDIES SHOULD BE REPORTED AND CTRP, THAT IS PRIMARILY THE SUPPORT DATA TABLE FOR SUBMISSIONS. WE THINK IT'S ALSO IMPORTANT THAT WILL ALLOW PEOPLE WHO HAVE ACCESS TO CTRP TO DO COMPREHENSIVE PORTFOLIO ANALYSIS. PROMOTES PUBLIC AWARENESS OF OBSERVATIONAL STUDIES AND HOW THEY CHANGE AS WELL. AND WE THINK THAT AS WE DO THAT, WE WANT TO BE THOUGHTFUL ABOUT THE BURDEN PLACE ON INDIVIDUAL CANCER CENTERS AND HAVE ANNUAL ACCRUAL REPORTING. TAKE PLACE. AND CANCER CENTERS TIE THAT TO THEIR CCSG RENEWAL DATES. ANCILLARY CORRELATIVE STUDIES SHOULDN'T BE REPORTED TO CTRP, WE HAD A NUMBER OF QUESTIONS AROUND CURRENT VALUE IN ASKING FOR THAT. ONE OF THOSE IS DEFINEING WHAT IS ACCRUAL TO THOSE KIND OF STUDIES. WHO SHOULD BE REPORTING IT. THAT THERE OFTEN IS NOT A SEPARATE DOCUMENT FOR THOSE STUDIES. IN GENERAL DISCUSSION VALUE OF ANCILLARY CORRELATIVE FOR NCI STAFF AND CCSG. WE RECOMMEND NOT INCLUDING THOSE IN CTRP UNTIL TOPICS HAVE BEEN EXAMINED IN DETAIL. THE OTHER TWO RECOMMENDATIONS ONE TOXICITY ADVERSE EVENT REPORTING. AND IS NOT THAT WE THINK ADVERSE EVENT REPORTING IS NOT CRITICAL, WE DON'T THINK CTRP IS THE PROPER PLACE FOR THAT. ONE ISSUE WE DISCUSSED IS NO SERIOUS ADVERSE EVENTS ACROSS THE WHOLE PORTFOLIO. HOWEVER SAIE ARE REPORTING CLINICALTRIALS.GOV AND BY ASKING FOR THOSE DATA BE REPORTED TO CTRP HAVE SUBSTANTIAL REPORTING BURDEN. AND ALSO REQUIRE NCI TO ACTUALLY BE ABLE TO ACT ON THOSE SIEs -- SAEs IN AN APPROPRIATE MANNER. LAST RECOMMENDATIONS OUTCOME DATA, FEEL LIKE HERE CLINICALTRIALS.GOV ALREADY REQUIRES OUTCOME DATA BE POSTED. AND CTRP REPORTING OF DEIDENTIFIED PARTICIPANT LEVEL OUTCOME DATA WOULD BE TOO HIGH A BURDEN FOR CTRP USERS AND CANCER CENTERS THERE ARE ALREADY MECHANISMS FOR REQUESTING THOSE DATA. DID YOU WANT TO GO THROUGH THIS? >> THANKS WARREN, WE WILL TALK NOW ABOUT IMPROVEMENT OF THE CLINICAL TRIALS SEARCH. THE RECOMMENDATION OF THE WORKING GROUP IS STRUCTURE ELIGIBILITY CRITERIA AS FEASIBLE. CURRENTLY STRUCTURED ELIGIBILITY CRITERIA INCLUDE AGE GENDER AND BIOMARKERS, WE WOULD LIKE TO SEE PRIORITIZATION OF STRUCTURING ADDITIONAL ELIGIBILITY CRITERIA TO ENABLE PRECISE IDENTIFICATION OF THE CLINICAL TRIALS FOR PARTICIPANTS. SO THAT FIELDS WE WANT TO SEE INCLUDED IS THE CLINICAL SIGNIFICANCE. WHAT IS CLINICAL IMPORTANCE OF THE ATTRIBUTE CAPTURED IN THE CRITERION. HOW WE SEE AS STRUCTURE CRITERION ACROSS CLINICAL TRIALS. HOW MANY TRIALS LIST CRITERION. HOW PRACTICAL, OUR EASY FOR TYPICAL DOCTOR OR RESEARCH CLINICAL RESEARCH STAFF MEMBER TO DETERMINE WHETHER THIS CRITERION IS MET. AND DURABILITY IS THE CRITERION UNLIKELY TO CHANGE OVER TIME. ANOTHER HIGHLIGHT OF OUR CLINICAL TRIAL WORKING GROUP RECOMMENDATIONS WERE ACCRUAL TO PRECISION MEDICINE TRIALS. I WILL MENTION WE HAD A ROBUST DISCUSSION ABOUT THIS, CURRENTLY PRECISION TRIALS SUCH AS THE MATCH TRIAL THERE ARE MANY PATIENT WHOSE ARE SCREENED. AND FORMALLY ARE SIGNING INFORMED CONSENT FORMS AND ARE NOT ELIGIBLE FOR TREATMENT ON THAT TRIAL BECAUSE THEY DON'T HAVE THE MOLECULAR BIOMARKER. AND THERE IS CONFUSION I THINK IN THE FIELD ABOUT HOW TO BEST CAPTURE THIS INFORMATION. COUNT THAT AS ACCRUAL? COUNT IT AS ACCRUAL ONLY IF THE PATIENT IS RANDOM -- IS ELIGIBLE TO GO ON A PARTICULAR BIOMARKER STUDY. STAN MADE PARTICULAR POINT OF THIS WITHIN OUR SUBCOMMITTEE AND WE DISCUSSED IT QUITE VIGOROUSLY, AND MADE THE RECOMMENDATION ULTIMATELY REPORTING SCREENING OF PRECISION MEDICINE TRIALS SEPARATELY. FROM ACCRUALS TO THE INTERVENTION ARM. WE SHOULDN'T BE DOUBLE DIPPING NECESSARILY BUT WE SHOULD BE CAPTURING BECAUSE IT IS A VERY IMPORTANT LEGITIMATE TRIAL ACTIVITY REQUIRING ENORMOUS EFFORT ON PART OF PARTICIPATING INSTITUTIONS. WE THINK WOULD NOT INCLUDE FOR EXAMPLE SCREENING CONFORMANCE WITH TYPICAL HAD PRIOR MOLECULAR PROFILING STUDY DONE AND DETERMINED NOT ELIGIBLE FOR A PARTICULAR TRIAL, THAT WOULDN'T COUNT AS A SCREENING ACCRUAL. THIS WOULD BE SCREENING ACCRUALS, SPECIFICALLY TRIALS WHERE INFORMED CONSENT OBTAINED PRIOR TO GOING INTO THE STUDY. ANOTHER SOCIETY OF RECOMMENDATIONS RELATES TO CTRP DATA TABLE FOR INTERVENTIONAL TRIALS. WE RECOMMEND THAT THERE BE A PHASE TRANSITION TO CTRP GENERATED DATA FABLE FOR FOUR INTERVENTIONAL CLINICAL TRIALS. WITH FOR NON-COMPETING CCSG SUBMISSIONS IN FISCAL YEAR 18. COMPETING REVIEW SUBMISSIONS BEGINNING IN FISCAL YEAR 19. WITH A PHASE IMPLEMENTATION THAT PROVIDES ADDITIONAL TIME TO ADDRESS ISSUES THAT MAY ARISE DURING TRANSITION. SUCH AS RECONCILIATION OF QUARTERLY ACCRUAL REPORTED TO CTRP WITHIN A GRANT YEAR ACCRUAL TOTAL REQUIRED FOR DATA TABLE SO WE CAN SHORE THESE UP TO IMPROVE COMPLETENESS AND ACCURACY OF CTRP REPORTING BY CANCER CENTERS. SO WITH THAT WE SHOULD OPEN FOR DISCUSSION. YOU HEARD OUR RECOMMENDATIONS. WARREN, COME JOIN ME UP HERE, WE CAN ADDRESS THE QUESTIONS AS THEY COME UP. >> THANKS, LOU, THANKS, WARREN. GISELLE AND HENRY, THAT WAS A COMPREHENSIVE REPORT. IT IS OPEN FOR DISCUSSION AT THIS POINT. SEVERAL MEMBERS OF OUR GROUP SAT ON VARIOUS SUBCOMMITTEES SO WE MIGHT HEAR FROM MIKE LE BLANK AND WALLY CURRAN. MIKE, COMMENTS YOU WANT TO MAKE? >> I THINK PEOPLE ARE HAVING TROUBLE HEARING YOU. >> Q. I WAS GOING TO POINT OUT FOLLOWING THE COMMENTS BEFORE THERE WAS ROBUST DISCUSSION WHEN IT CAME TO THE TRADE OFFS BETWEEN THE VALUE OF ADDITIONAL INFORMATION AT CTRP VERSUS WHAT THE IMPACT THAT WOULD HAVE AT THE INSTITUTIONS. SO SOME OF THOSE THINGS GENERATED MULTIPLE CONFERENCE CALLS TO RESOLVE ISSUES. THE OTHER IMPORTANT ASPECT, AS A STATISTICIAN, IT SOUNDS DRY SOMETIMES WHEN YOU SEE AMBIGUITY OR INCONSISTENCY BUT THOSE ARE REALLY IMPORTANT ISSUES NOT JUST BECAUSE OF THE QUALITY OF THE DATA COMING INTO CTRP BUT ALSO IN TERMS OF WHAT EFFORT IT MEANS THE INSTITUTION TO COLLECT THAT DATA BECAUSE EACH OF THOSE AMBIGUITIES MEANS STAFF AT THE INSTITUTIONS HAVE TROUBLE ENTERING AS WELL. >> WALLY, ANY COMMENTS? >> NOT TOO MUCH ELSE. WARREN AND LOU DID A TREMENDOUS JOB LEADING THIS AND I THINK THERE WAS OPEN DISCUSSION ABOUT THE INTENDED AND UNINTENDED CONSEQUENCES WE COULD ENVISION OF THIS. BUT I -- WHAT I LIKE IS THE FACT THAT THERE'S CLARITY ABOUT THE RECOMMENDATION IT IS AND THERE'S CLARITY ABOUT SENSITIVITY TO THE BURDEN ON THE CENTERS. OF ADDITIONAL REQUIREMENTS. THE OTHER MEMBER OF THE THE GROUP IS LYNN MATRISIAN WHO COULDN'T BE HERE AND MY SENSE FROM WHAT I WAS TOLD IS SHE WAS IN FAVOR OF THESE THINGS WHEN SHE GOT IT FROM THE ADVOCATE POINT OF VIEW AND SHE WAS INTERESTED IN MAKING SURE THAT WE MAKE THESE KIND OF DATA PUBLIC WHERE POSSIBLE. >> I WOULD LIKE TO MAKE A COMMENT ABOUT THAT. WE HAD A LOT OF DEBATE ABOUT THE UNBLINDING CONCEPT, THERE WAS A CONCERN RAISED BY SOME THAT CERTAIN CANCER CENTERS PARTICULARLY THOSE THAT ARE COMPETITIVE MARKETPLACES, MIGHT BE NERVOUS ABOUT HAVING THE DATA OUT THERE AND AVAILABLE SO COMPETITORS CAN USE IT FOR OTHER PURPOSES UNRELATED TO THE QUALITY OF THE SCIENCE THAT'S BEING CONDUCTED. WE HAD A ROBUST DISCUSSION ABOUT THIS.& BUT I THINK AT THE END OF IT ALL WE CONCLUDED THAT SUNSHINE WAS BEST. HAVING THE INFORMATION OUT THERE AND AVAILABLE FOR PEOPLE TO SEE SO THAT ULTIMATELY OUR GOAL HERE IS THAT THE ADVOCACY COMMUNITY PATIENTS THEMSELVES PHYSICIANS IN THE COMMUNITY SCIENTISTS AND THE NCI ACCESS THAT WE ALL OCCUPY WOULD HAVE ACCESS TO THIS INFORMATION AND USE IT. THERE'S ENORMOUS DATA HERE. IT'S 500,000 ACCRUALS THAT CAN BE REVIEWED AND YOU CAN ACTUALLY SLICE AND DICE THAT IN SO MANY INTERESTING WAYS, THERE COULD BE FANTASTIC RESEARCH CONDUCTED WITH THIS REMARKABLE DATABASE BASE, NOT BY NCI BUT INTERESTED INVESTIGATORS AS WELL. AND WE FELT IT BEST O HAVE THIS AS TRANSPARENT AS FEASIBLE WHERE WE CONSISTENTLY DREW THE LINE WAS PROTECTION OF INDIVIDUAL SUBJECTS THAT WE JUST DIDN'T FEEL COMFORTABLE WITH SUNSHINE BEING SO BRIGHT, ZIP CODES WERE AVAILABLE SO THAT YOU MIGHT BE ABLE TO IF YOU WERE A CLEVER INDIVIDUAL TO FIGURE OUT WHO WAS TREATED FOR WHAT KIND OF CANCER. WE DIDN'T FEEL THAT WAS APPROPRIATE. >> JIM, DID YOU HAVE COMMENTS FROM THE NCI POINT OF VIEW? >> THIS IS A PROJECT THAT DIDN'T TAKE TWO YEARS BUT IN FACT TOOK BETTER PART OF A DECADE. THIS IS SOMETHING THAT'S ACTUALLY COME TO PASS BECAUSE IT WILL HELP EVERYONE, NOT ONLY THE STAFF AT THE NCI BUT AT EVERY CENTER TO KNOW, HAVE A BETTER IDEA WHAT'S GOING ON, ON A NATIONAL LEVEL SO WHEN YOU PLAN FOR WHAT YOU WANT TO DO YOURSELVES YOU'LL HAVE A BETTER IDEA WHAT THE ACCRUAL IS, AND SO ON SO FORTH. SO I'M GRATEFUL TO EVERYONE WHO IS PARTICIPATED. AND IN FACT, IT WASN'T EASY. BUT TO ALL OF THE CANCER CENTERS HAVE BEEN ABLE TO ADAPT THEIR REPORTING PROCESSES TO ALLOW THIS ESSENTIALLY REAL TIME REPORTING WHICH IS VERY, VERY COOL THING. >> OPEN FOR DISCUSSION. MEMBERS OF THE COMMITTEE, PLEASE. >> I THINK THIS IS A GREAT STEP FORWARD AND I THINK CLEARLY ADDRESSES ONE OF THE KEY AREAS MEANT TO ADDRESS CONSIDERED A GAP FOR THE NCI WHICH IS ABILITY TO MONITOR TRIALS AND ACCRUAL TO THOSE TRIALS. I NOTE THE OTHER GAPS WERE TO BE ABLE TO IDENTIFY GAPS IN DUPLICATIVE STUDIES AND ALSO TO EFFECTIVELY PRIORITIZE CLINICAL TRIALS. PUTTING YOU ON THE SPOT TO ADDRESS QUESTIONS NOW AFTER YOU FINISH THIS INITIAL BIG PHASE MAYBE UNFAIR BUT I WILL PRESS YOU A LITTLE. WHAT IS CURRENT THINKING HOW THE DATABASE WILL BE USED TO IDENTIFY GAPS AND DUPLICATIVE STUDIES AN PRIORITIZE TRIALS? >> WE FOUND IT DIFFICULT TO BOIL THE OCEAN. FROM SO I THINK >> THAT MAY HAPPEN ANYWAY. >> THAT'S TRUE. WE FOUND VERY DAUNTING TO GET TO WHERE WE ARE RIGHT NOW. THIS IS COMPLICATED STUFF. WE DID LEAVE A LOT OF FUTURE ACTIVITIES AND FEEL MORE WORK TO FURTHER DEVELOP THE CONCEPT. WE FELT BY FIRST GIVING NCI A CHANCE CONDUCT A PORTFOLIO ANAL ADDRESSES THESE ISSUES WAS A GREAT WAY OF DOING THINGS AND THE ABILITY TO ACTUALLY PROVIDE THE PROGRAMMING SUPPORT INTERNALLY, WITH NCI OUTSIDE INDIVIDUALS GAIN ACCESS TO THE INFORMATION ALLOW THEM TO AT LEAST IN AD HOC MANNER PERFORM THAT PORTFOLIO ANALYSIS. BUT CLEARLY MORE WORK IS NEEDED IN ORDER TO BE ABLE TO GO TO THE NEXT LEVEL. >> WHAT DIDN'T COME OUT IN THE DETAILED RECOMMENDATIONS IS WE SEE A LOT MORE STRUCTURED ELIGIBILITY FOR CLINICAL TRIALS BEING AVAILABLE AND WE THINK THAT AS THAT BECOMES EASIER FOR PEOPLE TO SEE SEARCH ON, IT WILL BE OBVIOUS WHEN NEW INVESTIGATOR COMES WITH A GREAT IDEA FOR CLINICAL TRIAL, ARE THERE CLINICAL TRIALS THAT OVERLAP WHAT I'M DOING? CAN I TAKE ADVANTAGE OF THOSE IF THEY'RE NATIONAL TRIALS, MULTI-CENTER TRIALS OR AT LEAST KNOW WHO TO CALL TO DECIDE IS THIS REALLY OVERLAP WITH MY TRIAL OR NOT, AM I ASKING THE SAME KINDS OF QUESTIONS. AS WE MOVE FORWARD IT WOULD BE GREAT TO SEE EVEN BACK TO LETTERS OF INTENT AVAILABLE TO PEOPLE SO YOU KNOW AS SOON AS POSSIBLE TRIALS ARE BEING CONSIDERED. BUT AGAIN, AS WE SAID, WE NEED THE WALK BEFORE WE RUN. >> I WOULD ALSO JUST ADD TO THAT, ONE OF THE EARLIER SLIDES WARREN'S PART OF THE PRESENTATION, REMEMBER THAT HE NOTED THAT RIGHT NOW ANYBODY GAINS ACCESS TO THIS DATA, JUST NEED A SOPHISTICATED COMPUTER PROGRAMMER WHO KNOWS THE CODE AND DO THE WORK THAT NEEDS TO BE DONE. THE PROBLEM IS MOST OF US DON'T HAVE AVAILABLE TO US INDIVIDUALS WITH THAT PARTICULAR SKILL SET EXPERTISE PERSPECTIVE TO BE ABLE TO DO THIS. ONE OF THE THINGS WE TALKED ABOUT WAS BASICALLY HOUSING THAT EXPERTISE WITHIN NCI SO YOU CAN MAKE A QUERY AND GAIN ACCESS TO THE INFORMATION IF YOU WANTED TO THROUGH SOME KIND OF STRUCTURED ENGAGEMENT. THAT'S ONE OF THE THINGS WE LIKE TO SEE HAPPEN. >> COMMENT AROUND PRIORITIZING. WE HAVE STEERING COMMITTEES AND PEOPLE ARE LOOKING AT A CONCEPT. I THINK IT WILL BE NICE TO BE ABLE TO PROVIDE A REPORT THAT GIVES -- SUMMARIZES THE TRIALS THAT ARE GOING ON IN A PARTICULAR AREA. WITHIN THE NETWORKS AS WELL AS OUTSIDE TO THE EXTENT WE KNOW ABOUT THOSE. SO THAT IS ONE USE TO GIVE PORTFOLIO ANALYSIS. THOUGH AS LOU MENTIONED SOME OF THE REPORTING TOOLS NEED TO BE DEVELOPED TO MAKE EASY TO DO INDEPENDENTLY. RIGHT NOW NCI CAN PROVIDE THAT. >> GREAT REPORT. THANK YOU, VERY MUCH. I NOTED IN THE ANALYSES THAT YOU HAD BROUGHT FORTH -- I BELIEVE WARREN, THIS WAS IN YOUR REPORT. YOU ARE ANALYZING YEAR-ENDER AGE RACE ETHNICITY. HAVE YOU CONSIDERED ZIP CODES AS PART? THERE'S A PLETHORA OF INFORMATION INDICATING THAT CANCER OUTCOMES ARE RELATED TO ZIP CODES AND IMPORTANT FOR CANCER CENTERS. SO MY QUESTION IS DID YOU CONSIDER ZIP CODES AS PART OF THAT? OR WAS IT LEFT OUT? WAS IT EVER DISCUSSED IN IS >> IT WAS DISCUSSED QUITE EXTENSIVELY. GOOD THING ABOUT ANALYSIS OF ZIP SODSER CODES IS EXACTLY WHAT YOU DESCRIBED. WE'RE TALKING ABOUT COMPLETES TO DO THAT ON AGGREGATE DATA BUT RIGHT NOW ONE OF THE THINGS AS I RECALL AND SHEILA OR GISELLE, PLEASE REMIND ME, THE ZIP CODE OF THE TREATING INSTITUTION IS NOT RELEVANT, IT'S THE ZIP CODE WHERE THE PATIENT LIVES THAT YOU NEED TO DO. THE BALANCING ACT THAT WE HAVE HAD TO CONSIDER WITH OUR RECOMMENDATIONS IS, HOW GRANULAR DO YOU WANT TO GET? IF YOU GET DOWN TO ZIP CODE DATA, NOT SO MUCH LARGER AREAS WHERE THERE'S RESIDENTS IN PARTICULAR ZIP CODE GOING ON STUDIES, WHETHER YOU'RE IN PERHAPS A LESS DENSELY POPULATED AREA, YOU MIGHT END UP WITH POTENTIAL FOR PATIENT IDENTIFICATION INADVERTENTLY. SO THAT WAS WHAT WE BALANCED AS WE WERE DISCUSSING THESE ISSUES. AND I THINK THERE'S A COMFORT LEVEL TO SOME DEGREE WITH AGGREGATE INFORMATION BUT CERTAIN NOT AT THE INDIVIDUAL LEVEL. DO YOU WANT TO ADD ANYTHING? >> I THINK WHAT WE ALL FELT WAS REALLY IMPORTANT FOR NCI TO CONTINUE TO HAVE PATIENT LEVEL ZIP CODES FLOWING IN CTRP AND IN FACT ADS I MENTIONED THERE BE A METHOD OR PROCESS FOR INDIVIDUAL RESEARCHERS TO REQUEST THAT PATIENT LEVEL DATA. WE DIP THINK IT WAS APPROPRIATE TO PUT THAT OUT PUBLICLY. SO WE HAD A LOT OF DISCUSSION AROUND THAT. AGAIN, THAT'S ONE OF THE REAL VALUES OF THE ZIP CODE DATA IS UNDERSTANDING BOTH THE REACH OF AN INDIVIDUAL IN THE CANCER CENTER AS WELL AS THE DIFFERENCES IN CATCHMAN AREAS THAT DIFFERENT CANCER CENTERS HAVE. AND DOING A BETTER JOB NATIONALLY AT REACHING IN TO THE DIVERSE POPULATIONS THROUGHOUT THE UNITED STATES IS INCREDIBLY IMPORTANT. >> WHAT YOU'RE TALKING ABOUT IS THE ABILITY TO DO DATA ANALYSIS THAT ALLOW US TO DRILL DOWN A LITTLE BIT MORE WITH THIS MASSIVE DATA SET. AND ASK ARE THE OUTCOMES DIFFERENT IN DIFFERENT ZIP CODES AND IS PARTICIPATION RATE EQUIVALENT, ET CETERA. AND I THINK THAT WE NEED TO BE ABLE TO DO THAT BUT I THINK THAT THROWING THAT OUT THERE FOR EVERYBODY TO SEE WHEN WE DON'T YET KNOW HOW WE ARE ABLE TO FULLY PROTECT THE PRIVACY OF VICTIMS IS SOMETHING TO CONSIDER. JIM. >> I WANT TO TAKE THIS OPPORTUNITY TO GET INPUT FROM EVERYBODY ON THE COMMITTEE BECAUSE I DON'T REMEMBER, I THINK IT WAS WARREN, VERY FAST, ABOUT API AND SUBSEQUENT SEARCH CAPABILITIES. AND THE ISSUE AND IT'S PROBABLY DOESN'T ESCAPE ANYBODY'S ATTENTION, ONCE YOU NOW HAVE A COMPREHENSIVE WAY TO ALL THESE TRIALS TOGETHER THIS, THERE IS THE POSSIBILITY WITH ADDITIONAL WORK TO DEVELOP SEARCH TOOL THAT WOULD BE RELEVANT, MORE RELEVANT, THAN WHAT IS AVAILABLE. INTERESTED IN INPUT FROM EVERYONE IN TERMS OF WHETHER YOU THINK THAT'S AN ACTIVITY THAT WILL TAKE CONSIDERABLE AMOUNT OF WORK, WARREN, MAYBE YOU CAN ADDRESS THAT BUT LIKE TO HEAR FROM EVERYONE ABOUT THE INTEREST OF THE GROUP IN OUR CONTINUING TO PURSUE THAT. >> AGAIN, THIS WAS AN ACTIVITY I WAS PART OF WITH CANCER MOON SHOT BRINGING IN THE PRESIDENTIAL INNOVATION FELLOWS TO BUILD THE API. WE PUT OUT SAMPLE CODE TO MAKE IT POSSIBLE FOR ANYONE CANCER CENTER ADVOCACY GROUPS TO BE ABLE TO REACH API AND DISPLAY THAT DATA BUT YOU'RE RIGHT. IT'S NOT -- THAT'S CURRENTLY NOT AS SOPHISTICATED OR AS EASY TO DO AS IT NEEDS TO BE. >> JIM, THANKS FOR HIGHLIGHTING THIS ISSUE. THE AVAILABILITY OF THE API AND AUGMENTATION OF STRUCTURED DATA WILL ALLOW VARIETY OF ENTITIES. EVERYBODY DOESN'T NEED THE IN HOUSE TECHNICAL EXPERTISE TO WORK WITH THIS. BUT THERE ARE A NUMBER OF CANCER CENTERS THAT ARE ACTIVELY DEVELOPING TRIAL MATCHING APPLICATION, COMMERCIAL ENTITIES THAT ARE DOING THIS, AND I THINK THAT THE OPPORTUNITY IN TERMS OF TRIAL MATCHING ONCE YOU INCREASE AMOUNT OF AVAILABLE STRUCTURED DATA TO MATCH AGAINST IS A HUGE OPPORTUNITY AND POTENTIAL PLACE PUBLIC PRIVATE PARTNERSHIPS COULD BE LEVERAGED. >> PARTIALLY RELATED, I WANT TO COMPLIMENT YOU ON A COMPREHENSIVE REPORT. REALLY EXCITED TO SEE BIOMARKERS STARTING TO MAKE THIS IN TO COLLECTION DATA. THERE ARE INCREASING NUMBER OF ORGANIZATIONS RANGING FROM REQUIRING BIOMARKERS TO ANALYZING THEM, KNOWING WHERE TO GO TO ASK PEOPLE FOR THAT DATA WILL BE HELPFUL. DID YOU CONSIDER IMAGIN SINCE TRIALS NOT ONLY HAVE IMAGING CRITERIA BUT IMAGING RESPONE DATA, THERE IS A SIMILAR COMMUNITY BOTH IN INDUSTRY AND SPONSORED BY THE NCI AND OTHER ORGANIZATIONS TO DO THAT. AND THE BIGGEST TROUBLE I FIND IN WORKING WITH THAT ORGANIZATION, JUST DON'T KNOW WHERE TO GO TO ASK FOR DATA SETS. IS THAT PART OF THE BIOMARKER FIELD IMAGING? >> I MISSED PART OF YOUR QUESTION. WHICH ORGANIZATION ARE YOU NOT ABLE TO -- >> >> SIMILAR TO TISSUE BIOMARKERS THERE'S A NUMBER OF ORGANIZATIONS THAT ARE IN INDUSTRY, THERE'S A QUANTITATIVE IMAGING NETWORK THE NCI SUPPORTS. YOU HAVE NOW GOT INCREASINGLY IDENTIFIED FOLKS BOTH INDUSTRY AND PUBLIC DOMAIN THAT WILL TO THE SAME TYPE OF ANALYSIS OF IMAGING DATA TO OPTIMIZE IT DOING IT FOR BIOMARKER DATA. I'M NOT EXPECTING TO COLLECT IMAGES BUT COLLECTING WHICH TRIALS HAVE IMAGING DATA THAT MIGHT BE OF BENEFITS TO THOSE COMMUNITIES. >> ONE SIDE THAT HAS A REALLY IMPORTANT DISCUSSION AROUND THE IMAGING DATA COMMENTS THAT IS COMING OUT OF CANCER MOON SHOT, THAT SUPPORTS IMAGING FOLKS AND PROVIDES THEM WITH A MECHANISM FOR ANALYZING AND COMING UP WITH WHAT ARE THE FEATURES IN THESE IMAGES THAT IN FACT MAKE GOOD-BYE MARKERS. I THINK WE WERE ANTICIPATING THAT WHEN WE TALK ABOUT BIOMARKERS THAT'S -- THAT MEANS ANY FEATURE OF PATIENTS. >> BROAD DEFINITION OF THAT. >> I WAS THINKING OF LESS AMBITIOUS. IF YOU KNOW A PARTICULAR TRIAL IS USING CT AS WAY OF MEASURING RESPONSE, INVESTIGATORS LOOKING FOR LARGE DATA SETS MIGHT INVESTIGATE THOSE. >> LET ME TURN TO GISELLE WHO MAY HAVE COMMENTS. >> WE DO INCLUDE THE IMAGING TRIALS IN CTRP AND WE DO INCLUDE HOW THE OUTCOME IS BEING EVALUATED AND INSOFAR AS POSSIBLE MOVING TOWARDS TRYING TO GET BIOMARKERS CAPTURED IN IMAGING STUDIED CAPTURED IN A SYSTEMATIC STANDARDIZED FAG. >> I WANT TO THANK THE SUBCOMMITTEE FOR DOING ALL THIS WORK. AND I SUPPORT THE RECOMMENDATIONS BUT I HAVE A COUPLE OF QUESTIONS. I KNOW THAT THERE ARE TWO FOCUSED IN ON THE TWO ACTIVITIES THAT WILL INCREASE WORK FOR THE CANCER CENTERS THAT ARE CURRENTLY WHERE THEY'RE CURRENTLY NOT DOING IT. THAT IS ACTUALLY THE SEPARATE REPORTING FOR PRECISION MEDICINE SCREENING. I THINK THAT'S GREAT BECAUSE I WILL REFLECT THE AMOUNT OF WORK THAT'S INVOLVED TO GET DOWN TO THE ACTUAL ELIGIBLE PATIENTS WHO ENTER THE TRIAL. I THINK THAT THAT IS A GREAT FOR THE ANALYTICS. THE ONE QUESTION I HAVE IS THE OBSERVATIONAL STUDIES BEING -- SHOULD BE REPORTED, WHICH OF COURSE IS GOING TO BE MANDATORY. THIS IS ACTUALLY AN ACTIVITY THAT IS NOT BEING DONE VERY RADIOTEENLY ACROSS CANCER CENTERS. THEY ARE NOT REPORTING OBSERVATIONAL STUDIES, BEHAVIORAL STUDY, STUDIES IN THE IMMUNITY, STUDIES THAT -- COMMUNITY, STUDIES THAT DON'T INVOLVE CANCER PATIENTS SEEN OR PATIENTS AT ALL SEEN AT THE INSTITUTION. I'M WONDERING IF THERE WILL BE GUIDELINES IN TERMS OF WHAT OBSERVATIONAL STUDIES SHOULD BE ELIGIBLE OR SHOULD BE REPORTED. THIS IS A HUGE GAMUT OF OBSERVATIONAL STUDIES. THERE ARE MANY STUDIES IN COMMUNITIES WHERE INVESTIGATORS DON'T RECRUIT PATIENTS FROM THE CANCER CENTER. >> TO ANSWER YOUR SECOND QUESTION FIRST. WE THINK THAT IF IT'S SOMETHING THAN CANCER CENTERS WANT TO INCLUDE IN DATA TABLE 4 AS PART OF THEIR PORTFOLIO, IT SHOULD BE REPORTED CTRP AND THAT'S PROBABLY WE HOPE THE WAY RECOMMENDATION WILL BE WRITTEN. IF YOU BELIEVE CLINICAL TRIALS IMPORTANT ENOUGH TO YOU INCLUDE IN DATA TABLE IT SHOULD BE REPORTED TO CTRP. THAT GIVES LATITUDE TO INDIVIDUAL CANCER CENTERS TO DECIDE IS IT SOMETHING TO SEE IN DATA TABLE 4 OR NOT. LOU YOU CAN GIVE THE RIGHT ANSWER TO THAT VERSUS MY ANSWER. >> MY ANSWER IS NOT DIFFERENT. I THINK WE EITHER BELIEVE OBSERVATIONAL TRIALS AND NON-INTERVENTIONAL TRIALS ARE REAL SCIENCE OR DON'T. IF WE'RE CONDUCTING REAL SCIENCE AND HAPPENS NOT TO INVOLVE THERAPEUTIC INTERVENTION, IT'S STILL A PART OF WHAT WE DO AS CANCER CERTAINTY AND COLLECTING THAT INFORMATION AND ALLOWING NCI TO DO A PORTFOLIO ANALYSIS, ALLOWING THE LARGER COMMUNITY TO HAVE A BETTER UNDERSTANDING OF WHAT'S HAPPENING IS WORTH WILE ACTIVITY AND SOMETHING TO DISCUSS. IT IS A I WON'T CALL IT UNFUNDED MANDATE BUT PIT'S UNDERFUNDED MANDATE AND IT'S SOMETHING WE HAVE TO BE COGNIZANT OF BUT ON BALANCE, AGAIN, PRINCIPLE OF SUNSHINE HAVING MORE LIGHT SHED ON THIS IS A GOOD IDEA. >> I COMPLETELY AGREE WITH YOUR PHILOSOPHY. IT'S JUST YOU ARE SAYING THAT IT'S AT THE DISCRETION OF THE CANCER CENTER AND THAT OBSERVATIONAL STUDIES THEY REPORT. AND I THINK MORE CLEAR GUIDELINES MIGHT BE HELPFUL. >> I'M LOOKING AT HENRY, ANY COMMENTS, HENRY? >> ANY CANCER CENTER THAT WOULDN'T WANT TO REPORT ITS OBSERVATIONAL TRIALS. THEY'RE GOING TO HAVE TO DO IT SEPARATELY AS A SEPARATE DATA TABLE BECAUSE REVIEWERS WON'T ASSESS POPULATION SCIENCE PROGRAMS OR HAVE IT COME IN AS CTRP, AS PART OF OUR REPORT. >> I'M GLAD IT'S ELEVATED TO GREATER AWARENESS NOW FOR CANCER CENTER REPORTING. >> WE'RE COMING DOWN TO THE LAST COUPLE OF MINUTES. EDITH, PAT. ANYBODY ELSE? >> IN A MEETING WITH PATIENT ADVOCATES THE LAST WEEKEND AT ECOG AKRON I'M ASSIGNED ONE OF THE LEADERSHIP MEMBERS TO MEET WITH THE PATIENTS AND THEIR ADVOCATES, THEY WERE CONCERNED AS YOU REGARDING TRIALS SUCH AS THE MATCH TRIAL. WHERE THERE IS A LOT OF WORK FOR THE CENTERS AND THE SITES TO PARTICIPATE BUT CONCERNED THAT THE PATIENTS WERE NOT INCLUDED IN THE SCREENING GROUP. AND THAT THEY THOUGHT THIS WAS NOT SCREENING BECAUSE PATIENTS PUT A LOT OF WORK INTO SIGNING CONSENT, MAKING SURE SPECIMEN ARE AVAILABLE FOR ANALYSIS, SO FORTH. SO THEIR SUGGESTION WAS IS THAT THIS WASN'T SCREENING THEY WERE WORKING AS PART OF THE TRIAL. AND MAYBE CONSIDER OTHER TERMINOLOGY SUCH AS STEP ONE FOR SUBMISSION OF TUMOR, STEP TWO FOR BEING ASSIGNED TO A TREATMENT ARM AND STEP 3 ACTUALLY RECEIVING THERAPEUTIC INTERVENTION ON THAT TRIAL. SO JUST FOR YOUR INFORMATION, IT -- I RECEIVED ALL OF THIS OVER THE WEEKEND. THEY WERE CONCERNED ABOUT WHY THIS WAS CALLED SCREENING. AS OPPOSED TO ACTUAL SOME KIND OF ACCRUAL RECOGNITION. >> THANK YOU FOR THAT, EDITH. OBVIOUSLY OUR RECOMMENDATION IS ECHOING SYSTEM OF THOSE CONCERNS. I DON'T THINK THAT WE HAVE YET DRILLED DOWN DEEPLY ENOUGH TO NAIL DOWN THE TERMINOLOGY FOR EXAMPLE ABOUT WHAT WE'RE GOING TO CALL THIS. BUT WE THINK IT'S IMPORTANT THAT THERE ARE AT LEAST BE A WAY OF COLLECTING THE INFORMATION ON HOW MANY INDIVIDUALS WHO CONSENTED TO UNDERGO INTERVENTIONAL PROCEDURE SUCH AS A BIOPSY OR CT, WHATEVER, WOULD HAVE A -- THERE WOULD BE A RECOGNITION THAT THIS WORK HAD BEEN DONE AND X NUMBER OF PATIENTS HAD GONE THROUGH THAT PROCESS. SO I THINK WE'RE HOPEFULLY BASED ON THESE RECOMMENDATIONS NCI WILL BE ABLE TO FORMULATE A VOCABULARY AROUND THIS, THAT WILL ALLOW ALL CANCER CENTERS AND ALL STUDY SITES TO HAVE AT LEAST A RECOMMENDATION IN ADDITION OF THAT ACTIVITY IN SOME WAY SHAPE OR FORM. >> THANK YOU. >> JUST TO ECHO THAT, ONE OF THE DISCUSSIONS WE HAD WAS IT'S NOT JUST BURDEN FOR THE CANCER CENTERS, IT'S RISK AND BURDEN FOR PATIENTS AS WELL SCREENED AND MAKING SURE AGAIN THAT THAT ACTIVITY BE REFLECTED IN ACCRUAL SOMEHOW. >> >> MY COMMENTS MAYBE OBTUSE. GREAT WORK. I WANT TO GO BACK TO WHAT EDITH SAID ABOUT THE PATIENTS AND ADVOCACY. I'M WONDERING WHETHER -- ONE, I DON'T WANT MORE WORK ON CANCER SENT E HOWEVER IF I WAS A PATIENT, I WOULD HAVE NO PROBLEMS WANTING TO HAVE MY ZIP CODE OUT THERE. I WOULD ACTUALLY -- IF I WAS ENTERED ON THE MATCH AND I HAVE SPOKEN ABOUT THIS BEFORE I WOULD ACTUALLY REALLY LOVE TO KNOW IF A NEW MARKER STUDY WAS AVAILABLE BESIDES MATCH THAT ANOTHER NCI CENTER WAS DOING. AND TO BE ABLE TO HAVE A PAY BACK TO THE PATIENT FOR GOING ON A TRIAL HERE IS A NEW TRIAL INSTEAD OF TELLING THEM THEY CAN DO SEARCH ON CLINICALTRIALS.GOV WE HELP DO THIS. SO I HOPE, AND I WONDER WHETHER OR NOT Z YOU TALK PROTECTION OF THE PATIENTS, AND LYNN IS PRIMARY AD VIE KATE, WHETHER OR NOT REALLY POLLED A BUNCH OF PATIENTS IN A BROADER SENSE I SUSPECT THAT THIS CONCERN YOU HAVE ABOUT ZIP CODE WOULD PROBABLY VANISH. IN A BROADER GROUP. >> CERTAINLY POSSIBLE. I WILL SAY AGAIN, I THINK THE PRIME CONSIDERATION THAT WE HAD WAS REALLY PROTECTION OF PRIVACY HERE. AND YOU MAY BE -- MAY WELL BE CORRECT, THAT IS NOT AS BIG A CONCERN OR ISSUE FOR INDIVIDUALS AT THE LEVEL OF THE PATIENT. BUT I THINK AT THE LEVEL OF NCI THEY HAVE TO MAKE SURE THAT THEIR POLICIES ARE PROTECTING OF THOSE INDIVIDUAL PRIVACY RIGHTS. SO THIS IS A SUBJECT TO CONTINUE EXLORE PROBABLY NOT TODAY BUT TIME TO MOVE FORWARD WITH PERHAPS THE RECOMMENDATIONS AT THIS POINT. >> JUST A -- WE HAVE A COUPLE MORE COMMENTS. ED. >> RELATED TO GLORIA'S COMMENT I WANT TO SUPPORT THE IDEA OF INCLUDING OBSERVATIONAL STUDIES AND REALLY A LITTLE BIT AGREE WITH A LITTLE BIT MORE STRUCTURE OR MANDATE AROUND THAT. AND I WAS LOOKING AT THE FULL REPORT WHERE IT SAYS TYPE OF REPORTING IS CONSISTENT WITH CLINICALTRIALS.GOV REQUIRES CURRENTLY, WHICH I DON'T CARRY IN MY HEAD BUT I WOULD SAY IN TERMS OF BIOMARKERS WHERE THE STATE OF SCIENCE IS SUCH THAT WE DO NEED OBSERVATIONAL STUDIES WITH BIOMARKERS LONGITUDINALLY TO UNDERSTAND SOME THINGS THAT BIOMARKERS NOT PART OF ELIGIBILITY BECAUSE WE DON'T KNOW YET WHAT THAT MIGHT BE. BE INCLUDE BECAUSE THAT IS A VERY IMPORTANT AREA I THINK IN MANY AREAS INCLUDING SYMPTOM MANAGEMENT. >> ONE CONCERN WE HAD IN CONSIDERING THAT WAS THAT SINCE BIOMARKERS MANY IS DAS SOMEWHAT FLEECES STRUCTURED BECAUSE IDIOSYNCRATIC AND MANY TIMES EXPLORATORY IN NATURE AS OPPOSED TO WELL DEFINED ELIGIBILITY CRITERIA SUCH AS PERFORMANCE STATUS, ET CETERA. I THINK THAT THERE WAS LITTLE BIT RELUCTANCE TO INCLUDE THOSE BIOMARKERS UNDER THOSE CIRCUMSTANCES UNLESS THEY WERE ACTUALLY PART OF THE ELIGIBILITY CRITERIA. FOR ANYTHING. WE DIDN'T BREAK IT DOWN BY OBSERVATIONAL VERSUS THERAPEUTIC IN THAT CONTEXT. >> DID YOU HAVE A COMMENT? >> WOULD THE BIOMARKER BE AVAILABLE AS PART OF THE STRATIFICATION FACTOR INTERVENTIONAL TRIAL OR INTEGRATED OR INTEGRAL PART OF ANY STUDY WE WOULD CAPTURE IT IN A STANDARDIZED FASHION AS PART OF THE ABSTRACTION. I THINK THIS THRUST FOR OBSERVATIONAL STUDIES WAS TO BE MINIMALISTIC FOR REASON DISCUSSED HERE. BUT WITH THE PROTOCOL DOCUMENT, WITHOUT ADDITIONAL BURDEN TO SUBMITTER WE COULD CAPTURE BIOMARKERS IN A CONSISTENT STRUCTURED WAY. >> LAST COMMENT FROM STEVE. >> FIRST I WANT TO ECHO WHAT'S SAID ABOUT THE VALUE OF THIS INITIATIVE. YOU'RE GOING IN THE RIGHT DIRECTION. A NUMBER OF US PARTICIPATING IN RYAN WERE ACTUALLY DOING INFORMED CONSENT AT TIME, ALL OUR PATIENTS PRESENTED, PART OF REGISTRY AND ALL MOLECULAR DATA WILL BE MADE AVAILABLE IN ANONYMOUS WAY. BUT ALSO WE LOOK AT THAT INFORMATION DECIDE WHO MAY GO ON SOME OF THESE TRIALS. NOT SURE HOW THIS WILL BE INCORPORATED. >> THANK YOU. >> I JUST ONE COMMENT. THE TIME LINE FOR TRANSITIONING CTRP TO DATA TABLE 4 LOOKS BRISK TO ME. NON-COMPETING RENEWALS DOING IT RIGHT NOW. SO I'M SURE THAT THE CANCER CENTER PROGRAM IS LOOKING TO MAKE SURE IT'S FEASIBLE. WITH THAT, WE FINISHED OUR DISCUSSION, YES, AND LOU I THINK OUR JOB AS COMMITTEE WOULD BE TO ENTERTAIN A MOTION TO ACCEPT THIS WONDERFUL REPORT. SECOND? ALL IN FAVOR? AYE. ANY ON POSED? THANK YOU, VERY MUCH FOR YOUR HARD WORK. APPRECIATE I. -- ANY OPPOSED? THANK YOU VERY MUCH FOR YOUR HARD WORK. APPRECIATE IT. OUR SECOND TOPIC TODAY IN CLINICAL TRIAL SPACE HAS TO DO WITH EFFORTS GOING TON TRY TO REDUCE TRIAL BARRIERS AND DOING THAT IN PART BY LOOKING AT OUR ELIGIBILITY CRITERIA MORE INCLUSIVE. TO LOOK AT SOME OF THE INFORMED CONSENT TEMPLATES CURRENTLY UNDER REVISIONS. TO LOOK AT SOME OF THE INFORMATION THAT HAS TO DO WITH NATIONAL COVERAGE ANALYSIS ACROSS NCI NETWORK TRIALS TO PROVIDE COMMONALITIES AND HARMONY AS WE THINK ABOUT THIS ACROSS THE NCI. WE'RE LUCKY TO HEAR FROM ANDREA DENICOFF IN CTEP AND HEAD OF CLINICAL TRIALS OPERATION FOR NCTN. ANDREA. >> THANK YOU. GOOD MORNING, EVERYONE. HAPPY TO BE HERE. FOR THOSE WHO DON'T KNOW ME, MY BACK GROUND I'M ONCOLOGY NURSE RESEARCH NURSE, ONCOLOGY NURSE PRACTICER AND THOSE WHO WORK WITH ONCOLOGY NURSES WE DO LOTS OF EVERYTHING. I HAVE BEEN DOING THIS FOR OVER 30 YEARS AND JUST PASSIONATE ABOUT MAKING A DIFFERENCE FOR OUR TRIALS TO COMPLETE. AND TO BE AS INCLUSIVE AS POSSIBLE FOR OUR PATIENTS. SO THESE THREE TOPICS ACTUALLY DO HAVE SOME INTERRELATION. THE THREE I WILL COVER TODAY THE FIRST ONE IS REALLY A MAJOR TEAM EFFORT BETWEEN ASCO FRIENDS OF CANCER RESEARCH AND A HUGE NUMBER OF PARTICIPANTS JUST TO MAKE SURE EVERYONE'S AWARE OF THIS EFFORT AND DESCRIBE BRIEFLY HOW TO IMPLEMENT THIS IN OUR CTEP TRIALS. THE SECOND TOPIC IS HOW WE REVISED THE NCI INFORMED CONSENT TEMPLATE INCLUDING THE NEW COMMON RULE REQUIREMENTS THAT WERE LAID OUT IN LAST JANUARY. THIRD TOPIC IS EFFORTS TO PROVIDE NATIONAL COVERAGE ANALYSIS IN OUR NETWORK TRIALS. SO THE FIRST EFFORT I HOPE YOU HAVE SEEN THIS ALREADY, THAT ASCO AND FRIENDS OF CANCER RESEARCH HAVE BEEN PROMOTING BROADLY TO BROADEN ELIGIBILITY CRITERIA IN OUR TRIALS. SO I'M PRESENTING THEIR INFORMATION AND I WAS LUCKY ENOUGH TO BE PART OF THIS EFFORT AS WELL. SO THE ASCO FRIENDS PROJECT AS I'LL REFER TO PUT TOGETHER STAKE HOLDER GROUP THAT INCLUDED JUST A VAST NUMBER OF STAKEHOLDERS FROM PATIENT ADVOCATES, INVESTIGATORS, THE FDA, NCI, PHARMACOLOGIST, BIOSTATISTICIANS DRUG AND BIOTECH. REALLY PULLED THE ENTIRE CANCER COMMUNITY TOGETHER AND PRIORITIZED FOUR MAJOR AREAS OF HOW TO PUBLISHED TRIALS. THEY PUBLISHED FOUR PAPERS, THEY'RE WELL DONE AND REALLY OUTLINE DATA DRIVEN EVIDENCE HOW WE CAN MAKE THESE ELIGIBILITY IN OUR TRIALS INCLUDING FOR BRAIN PATIENTS WITH BRAIN METASTASIS, MINIMUM AGE OF SOME TRIALS DOWN TO AGE 12. INCLUDING PATIENTS WITH HIV IN OUR TRIALS. DYSFUNCTION COMORBIDITIES AN PRIOR AND CONCURRENT MALIGNANCIES. SO I WON'T READ THEM ALL BECAUSE WE'RE BEHIND BUT BASICALLY WITH THE BRAIN METASTASIS, MINIMUM AGE HIV AND ORGAN DYSFUNCTION IS IN FOUR PAPERS THAT OUTLINED DETAILED INFORMATION HOW THESE CAN BE DONE AND PROVIDE SUCCESSFUL EVIDENCE WHERE THEY HAVE BEEN INCLUDED IN TRIALS. I KNEW SOME NCTN TRIALS INCLUDING THESE RECOMMENDATIONS ALREADY AND HOW THEY ARE MAKING IMPROVEMENTS. AND INCLUDE PATIENTS WITH PRIOR MALIGNANCIES. PATIENTS ARE I'VE WILLING LONGER MORE SUCCESSFULLY IN EARLY STAGE TRIALS AND WE NEED TO INCLUDE THEM AND SOME ADVANCE STAGE TRIALS WITH NEW CANCERS. THE ASCO FRIENDS HAD A MEETING THIS SUMMER AND WROUGHT EVERYBODY TOGETHER HOW WE CAN EDUCATE AND INCREASE AWARENESS TO DO THIS. AND ONE OF THE IMPORTANT THINGS I THINK THEY DID IN ALL THEIR PAPERS IS DRAFTED TEMPLATE LANGUAGE FOR INCLUSION INTO PROTOCOLS. EVERYBODY TO WRITE A SCIENTIFIC PAPER BUT MAKE ACCESSIBLE TO PUT INTO OUR PROTOCOLS IS THE STEP WE NEED. THIS LINKS BACK TO WHAT MY PRIOR PRESENTERS FOR CTRP CAN BE STRUCTUREDDED IN A WAY, ELIGIBILITY OF STRUCTURE FOR INCLUSION OF BRAIN METASTASIS. STRUCTURE INCLUSION FOR HIV, POTENTIALLY BE A SEARCHABLE TRIAL IN A CLINICALTRIALS.GOV. SO IF I'M A PATIENT WITH HIV, I CAN NOW IN THE FUTURE HOPEFULLY LOOK FOR A TRIAL THAT I CAN FIT. BECAUSE RIGHT NOW IT IS NOT POSSIBLE. SO I THINK THIS WILL HELP PATIENTS HELP PROVIDERS IF WE CAN USE THIS STRUCTURED LANGUAGE. IN OUR TRIALS. IN TERMS OF MAKING THIS HAPPEN, THE GROUPS NEED TO WORK TOGETHER TO MAKE THIS HAPPEN AND ASCO FRIENDS AT THE END OF THE MEETING TALKED ADDITIONAL ELIGIBILITY CRITERIA HOW TO EXPAND TO OTHER AREAS. WITHIN CTEP E EARLY THERAPEUTIC CLINICAL TRIALS NETWORK HAD A FIRST MEETING TO DISCUSS HOW WE CAN BRING THIS IN TO OUR EARLY THERAPEUTICS TRIALS AND WE START WITH A NEW CENTRALIZED PROTOCOL OFFERING EFFORT AND WILL USE THE ELIGIBILITY CRITERIA AS PART OF IT AND DR. SAROSI AND HER TEAM WILL LOOK HOW TO BEST STRUCTURE THE ELIGIBILITY INTO OUR PROTOCOLS. THEN FOR THE NCTN YOU KNOW THAT IT'S A NETWORK OF GROUPS. EACH GROUP HAS DIFFERENT COMMITTEES, DIFFERENT DISEASE COMMITTEES AND WE HAVE TO FILTER ALL THIS INFORMATION INTO EACH COMMITTEE. BECAUSE JUST BECAUSE SWAG AND ALLIANCE LEADERSHIP ARE WARE OF THIS AND WANT TO DO THIS, IT IS GOING TO HAVE TO WHERE RUBBER MEETS THE ROAD IS AT THE GI STEERING COMMITTEE. AND THEY HAVE TO TAKE THESE AND PUT THEM INTO DIFFERENT PROTOCOLS. THIS IS GOING TO TAKE A TEAM EFFORT. IN ADDITION WE HAVE WHAT WE CALL NETWORK ACCRUAL CORE TEAM THAT I BELIEVE I CAME TO THIS GROUP A YEAR AND A HALF AGO TO PRESENT HOW WE HAVE REPRESNTATIVES FROM ALL THE NETWORK GROUPS WORKING TOGETHER HOW TO SUPPORT ACCRUALS TO THE TRIALS AND WE HAD A SMALLER TASK FORCE WITHIN IT AND WE WORKED TOGETHER WITH OPERATIONS LEADERS, SITE INVESTIGATORS RESEARCH COORDINATORS PATIENT ADVOCATES TO ALSO TACKLE ELIGIBILITY. WE'RE DOING A BOTTOM UP TOP DOWN APPROACH WITH DISSEMINATING THIS WITHIN THE GROUPS. BUT THERE CERTAINLY WILL BE CHALLENGES TO IMPLEMENTING THIS. WE'LL NEED FDA ROLE BE IMPORTANT IN OUR TRIAL COLLABORATIONS AND DR. PAZDUR AND FDA WERE INVOLVED IN THIS EFFORT AND HE WILL MAKE SOME COMMENTS AT THE END AND PIs AND STUDY TEAMS ARE COMMITTED TO THIS. IT'S VERY COMMON FOR INVESTIGATORS OR PROTOCOL TO REUSE THE ELIGIBILITY FROM THE PAST TRIAL. WE NEED TO STOP AND TAKE A LOOK AT WHAT'S REALLY NEEDED FOR EACH TRIAL. NOT JUST REUSING OLD CRITERIA. SITE INVESTIGATOR VERSUS TO MODIFY THEIR PROCESSES BECAUSE EVEN IF WE CHANGE THIS IN THE PROTOCOL WHEN I'M INVESTIGATOR AT A SITE AND INTERVIEWING YOU AS PARENT WITH CO-MORBID -- PATIENT WITH COMORBIDITIES I MAY HAVE A INTERNAL BIAS I MAY IN THE BE AS WAY WARE THAT I'M NOT GOING TO NOT OFFER THIS TO YOU SO EDUCATE THE SITES TO BE INCLUSIVE IN THINKING WHEN DISCUSSING TRIALS WITH OUR PATIENTS. SO IT'S GOING TO TAKE A MAJOR TEAM EFFORT TO IMPLEMENT THIS AND MAKE IT WORK. THE NEXT TOPIC IS REVISIONS TO INFORMED CONSENT TEMPLATE. THE NCI INITIALLY STARTED A BOILERPLATE BACK IN THE '90s AND YOU CAN SEE THROUGH THE TIME LINE WE HAVE MADE IMPROVEMENTS OVER THE YEARS. THE LAST LAUNCH WAS IN 2013, MANY OF YOU WE HAD STAKEHOLDERS ALL OVER THE COUNTRY INVOLVED IN REDESIGNING THE TEMPLATE TO BE MUCH MORE CONCISE AND HAVE CLEAR LANGUAGE T. WE HAD EFFORTS SINCE THEN LOOKING AT COMPLIANCE OF THAT USE. AND SEEING WHAT AREAS STRUGGLES WITH PEOPLE COMPLYING WITH IT. WITH THAT REVIEW WE HEARD BACK FROM MANY PEOPLE ACROSS THE COUNTRY, PARTICULAR AREAS OF CONCERN. WITH THE COMMON RULE LANGUAGE COMING OUT LED TO THE NEXT REVISIONS. WE HAVE HEARD RUMORS OHRP MAYBE CONSIDERING DELAYS IN IMPLEMENTING PARTS OF THE COMMON RULE BUT NOT SURE WHICH. SO WE NEED TO MOVE TO INCLUDE THE NEW REQUIREMENTS SO INVESTIGATORS HAVE ACCESS TO THE INFORMATION TO IMPLEMENT. THE PROCESS IS THAT WE HAVE HAD INTERNAL REVISION WITHIN THE NCI. WE HAD A STAKEHOLDER REVIEW WITH PARTICIPANTS FROM ALL OVER THE COUNTRY. DIFFERENT EXPERTISE FROM PATIENT ADVOCATES TO BIOETHICISTS TO INVESTIGATORS. AND WE DID A FIRST EFFORTS THEN THE COMMON RULE CAME OUT, WE HAD TO DO A SECOND EFFORT INCORPORATING THE NEW REQUIREMENTS THEY POSTED DID ANOTHER WHOLE REVIEW. WE WORKED HARD AT THE END WITH A PLAIN LANGUAGE SPECIALIST WHO CHALLENGED US ON MANY WAYS WE WRITE OUR CONSENT TO MOVE US TO USE LANGUAGE MUCH MORE ACCESSIBLE FOR ALL PATIENTS TO NOT WORRY HEALTH LITERACY STATUS AND THE THEN PUBLISH THIS IN OCTOBER. SOME OF THE KEY THINGS WE DID CHANGE IN ADDITION TO OHRP COMMON RULE REQUIREMENTS IS WE TRIED TO USE SOME FORMATTING CHANGES TO HELP AUTHORS. WE PUT A LOT OF NEW INFORMATION EXAMPLES FOR AUTHORS HOW TO DISCUSS GENOMIC PATIENTS. ALCHEMIST AND REVIEWING CONSENT I SEE EVERYBODY DESCRIBES IT DIFFERENTLY, TRYING TO PROVIDE EXAMPLES TO AUTHORS HOW TO SAY IT IN A WAY THAT PATIENTS CAN UNDERSTAND IT. WE SPEND TIME ALSO CLARIFYING SECTIONS THAT DEAL WITH COST COST FOR PATIENTS AND EXAMS AND DELL LINEATE FOR PATIENTS TO UNDERSTAND THAT'S PART OF WHAT THEY WERE GETTING REGULAR CANCER CARE VERSUS WHAT IS RESEARCH SPECIFIC. I WON'T READ THIS BUT COPY AND PASTED TO YOU CAN SO ON YOUR OWN LEISURE THE REQUIREMENTS, COMMON RULE ADDED SPECIFICALLY IN ADDING A NEW FRONT SECTION TO& OUR CONSENT, DEALING WITH KEY INFORMATION. SO THE KEY DATES, COMMON RULE TELLS US IN JANUARY 19th PROTOCOLS THAT ARE INITIALLY APPROVED BY CENTRAL IRB ON OR AFTER THIS DATE MUST USE REVISED INFORMED CONSENT TEMPLATE. ANYTHING WITH APPROVAL PRIOR TO JANUARY 19, 2018 DOESN'T NEED TO USE BUT AFTERWARDS THEY WILL. TO GET THIS INFORMATION OUT THERE BECAUSE WE KNOW PEEP ARE WRITING PROTOCOLS NOW AND NEED ACCESS TO THIS INFORMATION. AND THEN YOU ARE WELCOME TO PROVIDE COMMENT WE SET UP A SPECIAL EXMAILBOX, WE O SEE THIS AS A LIVE DOCUMENT, SCIENCE IS CHANGING RAPIDLY WE NEED TO IMPROVE LANGUAGE FOR OUR PATIENTS TO HELP THEM UNDERSTAND AND THANKS TO EVERYONE THE ENTIRE COMMUNITY FOR GIVING US FEEDBACK. SO THE LAST OF THE THREE TOPICS IS ON NATIONAL COVERAGE ANALYSIS AND HOW THEY HELP US REDUCE BARRIERS TO OUR TRIALS. FOR THOSE NOT FAMILIAR WITH THIS TERM, OUR WORKING DEFINITION IS THAT A NATIONAL COVERAGE ANALYSIS IS A REVIEW OF ALL THE TEST PROCEDURES AND INTERVENTIONS ASSOCIATED WITH CLINICAL TRIAL THAT DETERMINE WHICH ONES ARE BILLABLE AND WHICH ARE NOT BILLABLE. WHILE WE DON'T CONSIDER THIS ASPECT OF CLINICAL RESEARCH IT'S PART OF WHAT WE DO AND THOSE AT CANCER CENTERS KNOW THIS BECAUSE YOU NOW REQUIRE ALL YOUR TRIALS TO UNDERGO THIS. SO WHAT WE DO AS CORE RESOURCE DETERMINING NATIONAL COVERAGE ANALYSIS IS WE USE CENTERS FOR MEDICARE AND MEDICAID SERVICES CMS COVERAGE DETERMINATION FOR ROUTINE COSTS AND CLINICAL TRIALS. OTHERWISE REFERRED TO AFFECTIONATELY AS NCD 310.1. JUST A FEW EXPERTS WHAT DO WE MEAN BY ROUTINE COSTS AND THE CMS LANGUAGE. ITEMS OR SERVICES PROVIDED ABSENT THE CLINICAL TRIAL SO STANDARD OF CARE PATIENTS WOULD GET, AND INCLUDED THERE'S OTHER THINGS BUT I ALSO THOUGHT UNTILLED OBSERVE THIS PIECE THAT SERVICES NEEDED FOR REASONABLE AND NECESSARY CARE ARISING FROM THE PROVISION OF INVESTIGATIONAL ITEM OR SERVICE, IN PARTICULAR FOR THE DIAGNOSIS OR TREATMENT OF COMPLICATIONS. THIS IS DEFINITELY PLAINING INTERPRETABLE AND VARYING DEGREES ACROSS THE COUNTRY DEPENDING WHAT INSURANCE COVERAGE YOU HAVE. SO THAT'S WHY WE NEED TO USE A SOURCE, SUCH AS MEDICARE POLICY. SO THE NEED FOR PROVIDING THESE CENTRALLY CAME FROM A COMMUNITY GRASSROOTS EFFORTS OF SITES TELLING US THAT THIS IS COMPLEX WORK TO DO THIS BOTH AT THE ACADEMIC SITE AS WELL AS COMMUNITY SITE, EACH SIDE MUST INDEPENDENTLY CREATE ONE OF THESE BILLING GRIDS. AND REALLY INEFFICIENT AND COSTLY. IF WE HAVE TRIALS OPEN SUCH AS MATCH ACROSS A THOUSAND SITES THAT'S A THOUSAND SITES DOING THIS WORK OVER AND OVER. SO IN 2015, ASCO AND NCI PARTNERED TOGETHER, FOR SYMPOSIUM TO ADDRESS THIS ISSUE AND NEED TO THANK CONNIE CHAPONIC, ONCOLOGY NURSE AND ADMINISTRATOR OF THE N CORE IN GRAND RAPIDS AND LED A TEAM AT ASCO AND NCI A NUMBER OF COLLEAGUES WERE INVOLVED IN THIS, THIS WAS ANOTHER LARGE TEAM EFFORT TO ADDRESS THIS ISSUE. DETERMINES CREATING CENTRALIZED COVERAGE ANALYSIS COULD BE SOMETHING THAT WE CAN TAKE ON. AND THEN AS JULIE WAS PRESENT AT ASCO LED A WORKSHOP WITH AACI AND THEIR CLINICAL RESEARCH INITIATIVES TO SEE HOW WE CAN AGAIN IMPACT RECUSING ADMINISTRATIVE REGULATORY BURDENS. AND BOTH EFFORTS LED TO THE IDEA THAT NCI COULD PLAY A LEADERSHIP ROLE IN THIS SO WE CREATED A PILOT TO PROVIDE A CENTRALIZED RESOURCE TO DO THIS. AND ALSO HOPE TO INCREASE TRANSPARENCY OF WHAT NCI PROVIDES AND WHAT ADDITIONAL FUNDING MIGHT BE NEEDED FOR RESEARCH. WE WANTED TO REDUCE AND PREVENT PATIENTS FROM BEING BILLED BECAUSE THAT WAS ANOTHER THING WE WERE HEARING IF IT WASN'T EXPLICITLY COVERED WOULD PATIENTS BE AT RISK, INSTITUTIONS BE AT RISK. HOW CAN WE PREVENT ACCURATE BILLING ACADEMIC CENTERS DON'T WANT RISK FOR COMMITTING MEDICARE FRAUD BECAUSE THEY BILLED INAPPROPRIATELY AND BECAUSE THEY'RE NOT PREYLY CLEAR. HOW CAN WE INCREASE MEDICARE COVERAGE POLICY AMONG INSTITUTIONS AND WORK WITH LEAD ORGANIZATIONS TO HARMONIZE WHAT THEY'RE PUTTING IN A PROTOCOL WITH CLINICAL CARE GUIDELINES. THE NCI CANCER TRIAL SUPPORT UNIT WHICH IS OUR CONTRACT THAT IS THE HUB OF OUR NETWORK THAT PROVIDES SUPPORT TO NETWORK FORMED A COVERAGE ANALYSIS WORKING GROUP AND HAD ALL MEMBERS NCTN N CORE GROUPS INVOLVED WITH BILLING CONSULTANTS TO HELP US DO THIS CORRECT AND NCI STAFF SO WE STARTED IN MAY 2016 DOING THIS FOR SOME SELECT PHASE 2s AND 3s. AND HAD PROCESS CTSU START THESE DRAFTS AND REVIEW BY GROUP PIs. AFTER A YEAR WE SURVEYED RESPONDENTS ACROSS THE COUNTRY TO SEE HOW THESE WERE WORKING. SITES WERE ECSTATIC AND WE WEREN'T GETTING THEM OUT TIMELY BECAUSE WE STARTED THIS EFFORT. SO WE PRESENTED THE RESULTS OF THIS PILOT AS ASCO POSTER THIS PAST YEAR. SO I SAID WE HAD RESPONDENTS WITH HIGH SATISFACTION. SO IN TERMS OF PART OF THIS IS SUCCESSFUL IS I HAVE TO SHOUT OUT TO OUR CTAC MEMBER DR. ROSE MARY HAKIM WHO COLLABORATED WITH CMS ON THIS EFFORT AND SHARED HOW WE WERE WORKING ON THIS. THEY GOT INVITATION TO SPEAK TO MEDICAL DIRECTOR OS OF ALL THE MEDICARE ADMINISTRATIVE CONTRACTORS FROM AROUND THE COUNTRY SO WE CAN INCREASE AWARENESS TO THEM. AND HIGHLIGHTED SOME OF THE CHALLENGES WE'RE HAVING DOING IT BECAUSE WHILE WE PROVIDE ON A NATIONAL LEVEL THE DIFFERENT MEDICARE ADMINISTRATORS ALL HAVE DIFFERENT LOCAL COVERAGE DETERMINATIONS THAT VARY. SO WE CAN ONLY PROVIDE -- WE ONLY HAVE RESOURCES AT NATIONAL LEVEL SO WE WANTED TO MAKE THE MEDICAL DIRECTORS AWARE THAT THE MORE HARMONY THEY CAN PROVIDE IN ALIGNMENT OF SOME OF THE MEDICAL NECESSARY TESTS IN OUR TRIALS CERTAINLY HELP US COMPLETE OUR NATIONAL TRIALS MORE EFFICIENTLY. AND I CONSTANTLY HEAR FROM SITES WHY CAN'T NCI AND CMS WORK BETTER TOGETHER. BUT IT IS A HUGE EFFORT TO DO THIS ACROSS THE COUNTRY. SO OUR CURRENT EFFORTS, NOW WE'RE TRYING TO WORK TO DO THIS FOR ALL OUR TRIALS. WE HAD 22 TRIALS IN JANUARY WITH COVERAGE ANALYSIS AND NOW WE'RE HAVE OVER 67 TRIALS WITH COVERAGE ANALYSIS, 15 NCTN, 14 N CORE FOR MATCH WE HAD 31 AND THOSE ARE COMPLICATED. FOR LUNG MAP STUDY THAT IS AN UMBRELLA TRIAL WITH SIX NATIONAL COVERAGE ANALYSIS. AND NOW WE'RE ALSO GOING TO BE DOING AN EFFORT WITH OUR EARLY THERAPEUTICS CLINICAL TRIALS TO START THEM THERE. SO THIS DOES HAVE A LOT OF CHALLENGES TO IMPLEMENT. PROTOCOLS INFORMED CONSENT, REALLY HAVE NOT BEEN WRITTEN IN A WAY THAT HELPS BILLING EXPERTS DO THEIR JOB NOR SHOULD WE THINK WE WANTED TO DO THAT BUT UNFORTUNATELY THAT'S WHAT BILLING, THE INSTITUTIONS DO, THEY LOOK AT INFORMED CONSENT AND PROTOCOLS FOR THIS INFORMATION SO BY PROVIDING THEM THIS NATIONAL COVERAGE ANALYSIS, IT GIVES THEM A TOOL TO BETTER UNDERSTAND WHAT'S COVERED, WHAT'S NOT COVERED. THIS SORT OF LOOPS BACK TO INFORMED CONSENT PART BECAUSE WE PUT DIRECTIONS IN THE INFORMED CONSENT TO OUR AUTHORS SO THEY WILL BETTER CLARIFY WHAT'S PART OF ROUTINE CARE THAT MIGHT BE COVERED AND WHAT IS NOT. SO IT'S GOING TO TAKE AN EFFORT FOR EVERYONE TO BETTER WRITE THEIR PROTOCOLS IN A WAY THAT'S BASED ON NATIONAL GUIDELINES AND PUBLISHED PEER REVIEW EVIDENCE. SOME INVESTIGATORS SAY THIS IS STANDARD OF CARE AT CANCER CENTER X BUT NOT ACROSS THE COUNTRY WE HAVE TO MAKE OUR PROTOCOLS LOOK LIKE HOW CARE IS GIVEN ACROSS THE COUNTRY BECAUSE 30% ACCRUAL COMES FROM SITES IN THE COMMUNITY. SO SOME TRIALS IT'S MUCH LARGER THAN THAT SO WE HAVE THE MAKE OUR PROTOCOLS LOOK LIKE CARE ACROSS THE COUNTRY. SO IN SUMMARY, ALL OF THESE EFFORTS WILL TAKE CHALLENGES TO AND CONCERTED EFFORTS TO STAKEHOLDERS TO IMPLEMENT THE INFORMED CONSENT AS A LIVING DOCUMENT WE NEED YOUR FEEDBACK ON. AND WITH COVERAGE ANALYSIS THEY WILL REQUIRE COLLABORATIONS EARLY ON IN PROTOCOLS DEVELOPMENT. WHERE COSTS MAY NOT BE COVERED, WORK TO IDENTIFY SOURCES SO THAT RESEARCH COSTS CAN BE COVERED. PART OF THIS IS BARRIERS WILL CONTINUE TO ARISE AND CONTINUE TO HAVE TO WORK TOGETHER IN IF TEAM SCIENCE TO MAKE SURE COLLABORATIONS ADDRESS THEM. WE LOVE FEEDBACK AN AND INPUT ON ACCOMPLISHING THESE. >> THANKS. FABULOUS PRESENTATION. CAN YOU GO BACK TO YOUR PREVIOUS SLIDE BECAUSE MAYBE -- THERE'S SO MANY TOPICS HERE MAYBE WE CAN ORGANIZE OUR DISCUSSION AROUND EACH TOPIC. LET'S START WITH ELIGIBILITY CRITERIA AND AS SHE POINTED OUT RICK PAZDUR COULDN'T BE MORE IMPORTANT TO HEAR. WOULD YOU LIKE TO COMMENT ON THIS? >> THIS IS A PROJECT THAT WE HAD ONGOING FOR MANY YEARS NOW, LOOKING AT ELIGIBILITY CRITERIA. FROM OUR PERSPECTIVE ESPECIALLY IMPORTANT BECAUSE WE WANT THE CLINICAL TRIALS TO REPRESENT THE PATIENTS THAT ARE ULTIMATELY GOING TO BE USING THEM. SO WE HAVE BEEN WORKING ON THIS BEFORE THEIR FRIENDS AT ASCO TASK FORCE CAME UP. AT THE PRESENT TIME WHAT WE TRY TO DO IS OBVIOUSLY WORK WITH THEM WHEN THEY COME IN FOR THEIR END OF PHASE 2 MEETINGS AND EARLY CLINICAL DEVELOPMENT PLANS TO LOOK AT PATIENT POPULATIONS AND MAKE SURE ELIGIBILITY CRITERIA ARE NOT JUST AS MENTIONED BEFORE CUT AND PASTE FROM ONE PROTOCOL BUT THERE'S ACTUALLY A RATIONALE FOR WHY PATIENTS ARE EXCLUDED. THAT BEING SAID, OBVIOUSLY PEOPLE HAVE A CONCERN IF THEY HAVE A DRUG THEY ARE DEVELOPING AND COMPETITOR APPROVED AND THEY MAYBE ENTERING PATIENTS THAT MAY BE NOT AS ROBUST AS COMPETITORS SO WE SUGGESTED TO SEVERAL COMPANIES DIFFERENT WAYS ADDRESSING THIS, DIFFERENT STATISTICAL TECHNIQUES AS FAR AS EXCLUDING PATIENTS FOR THE PRIMARY ANALYSIS OF EFFICACYND SAFETY AND TAKING A LOOK AT SUBGROUP PATIENTS HIGHER RISK TO DEVELOP TOXICITIES. SO GROUP AND REVIEW TEAMS HAVE BEEN MAKING A CONCERTED EFFORT TO TAKE A LOOK AT THIS AND ADDRESS THESE PROACTIVELY RESPONSES AT THIS TIME >> SHORT TIME FOR DISCUSSION. OTHER COMMENTS ON ELIGIBILITY CRITERIA? PEOPLE WANT TO BRING UP? >> JUST ONE POINT. YOU HIGHLIGHTED ANDREA, THAT THE DATA SET PROVIDED BY KEISER TOABLE FORM WORK STREAMS ELIGIBILITY CRITERIA. THERE WERE A NUMBER OF REAL WORLD DATA SETS USED TO INFORM DESIGN OF OR SELECTION OF ELIGIBLE CRITERIA FOR SPECIFIC TRIAL, SEEMS TO ME THERE'S A GREAT OPPORTUNITY TO BRING THAT FORWARD AS A ROUTINE PART OF PLANNING OF CLINICAL TRIALS. THE FOUR PAPERS ARE SNAP SHOTS IN TIME AS NEW DRUG CLASSES COME ALONG, RELEVANT OR NOT RELEVANT AND THE REAL WORLD DATA SETS HELP US MAKE SURE THAT WE'RE BOTH NOT EXCLUDING PATIENTS, THAT COULD POTENTIALLY BENEFIT SO ACCELERATE THE PROGRESS. BUT ALSO HAVE RESULTS THAT ARE MORE GENERALIZABLE THAN TYPICAL CLINICAL TRIAL RESULTS. >> THANKS, HOWARD. SHORT COMMENT? >> FROM AN INDUSTRY PERSPECTIVE THAT I HAVE, WE DO CARE ABOUT ACCRUAL AND STUDY RULES AND ELIGIBILITY BUT WE ALSO CARE ABOUT THE HOW MANY EXPERIENCE THAT THE TRIAL RESULTS WILL SHOW AT THE END OF THE DAY. AND I HAVE SEEN THE NEED TO APPRECIATE THE OFF STUDY RULE, ON STUDY ELIGIBILITY IS GREAT BUT IF OFF STUDY RULES ARE COPY OVER FROM THE LAST TRIALS, THEN WE END UP IN INDUSTRY WITH A QUANDARY BECAUSE PATIENTS FOR INSTANCE THEY DON'T NEED A WINDOW OR THEY HAVE TO -- THEIR FRAIL ELDERLY CAN'T STAND ANOTHER CAT SCAN SO THEY HAVE AN ALTERNATIVE TEST. SO DOES THIS MAKE A DEVIATION, OFFICE OF SCIENTIFIC INTEGRITY COME IN AND SAY IT'S INVALID TRIAL. GLADLY WHAT I HAVE SEEN HAPPEN, AND I HAVE HAD DISCUSSIONS WITH OFFICE OF SCIENTIFIC DATA, THEY'RE SMARTER ABOUT THIS AND I THINK THERE CAN BE WAYS THAT THE ELIGIBILITY AND THE OFF STUDY RULES DURING THE CONDUCT OF THE TRIAL CAN SUPPORT THESE SUBGROUPS BUT IT HAS TO BE THOUGHT ABOUT PROSPECT TVLY. YOU CAN'T AFTER THE FACT SAY THIS WAS A FRAIL ELDERLY AND SO THEY COULDN'T LIVE UP TO WHAT WAS NEEDED SO THEY BECAME A DEVIATION. >> REALLY INTERESTING POINT. I WOULD LIKE TO MOVE ON TO THE NCI INFORMED CONSENT TEMPLATE DISCUSSION. IS THERE ANYTHING THAT PEOPLE WANT TO BRING TO ATTENTION OF THE THE COMMITTEE? >> ONE OF THE REALITIES IS THAT PATIENTS DON'T READ THE INFORMED CONSENT. I CAN'T THINK OF A SINGLE PATIENT I HAVE CARED FOR THE LAST DECADE THAT HASN'T JUST SAID BECOMING WITHIN HERE. I PERSONALLY THINK WE NEED DETAILED PIECE FOR LEGAL PURPOSES ONE PARAGRAPH, TWO PARAGRAPHS THAT THE INDIVIDUAL SIGNS THAT ACTUALLY SPELLS OUT IN LAY LANGUAGE, WHAT THIS TRIAL IS ABOUT. >> EDITH. >> MY COMMENT IS RELATIVE TO THE SAME TOPIC. AND THAT PATIENTS DON'T READ CONSENT FORM AND I WONDER IF THERE WAS ANY DISCUSSION ABOUT EITHER SIMPLIFYING THE CONSENT FORM SO THAT PATIENTS WILL READ IT OR EITHER SOMETHING RELATED TO THE LENGTH OF CONSENT FORM. CONSENT FORMS THAT ARE 20 PAGES LONG, NOT SURE THAT DOCTORS READ THEM. BUT PATIENTS CERTAINLY DON'T. WE'RE TALKING PATIENT PROCESS. I THINK WE HAVE TO LOOK AT LENGTH OF CONSENT FORM. >> ANDREA. >> THERE'S BEEN A NUMBER OF STUDIES LOOKING AT THAT AND PAGE LENGTH DOESN'T DETER WHETHER PATIENT GOES ON OR NOT, AND THAT GOES TO WHETHER OR NOT THEY'RE READING IT. THEY ARE A DOCUMENT, THEY ARE PART OF THE INFORMED CONSENT PROCESS AND I THINK IT'S PART OF A DISCUSSION AND SHOULD PART OF THE IT, UNFORTUNATELY THERE'S LOTS OF REGULATIONS THAT TELL WHAT WE HAVE TO INCLUDE AND THE LATEST NEW REGULATION PROVIDES ADDING ANOTHER TWO PAGES TO CONSENT BUT WHAT IT DOES DO IS I THINK THEY FEEL THE SAME WAY AS YOU DO. AND THE FIRST TWO PAGES ARE QUICK SUMMARY OF THE PROTOCOL. BUT WHAT I THINK IS ALSO A GOOD PART OF THIS, IS NEAL CONDUCTED A NCI FUNDED RO1 STUDY COMPARING PATIENTS USING A PREPARATORY VIDEOS ABOUT CLINICAL TRIALS AND IN HIS RANDOMIZE CONTROL TRIAL SHOWEDS THAT SAW VIDEOS PRIOR TO DISCUSSION WERE MORE RECEPTIVE TO HEARING ABOUT CONSENTS. THE MORE STUDIES I LOOK AT SEE THIS PREPARATORY EDUCATION OF PATIENTS REALLY IS A HELP. SO IT'S A GENERIC, THERE ARE VIDEOS ALREADY POSTED ON THE ASCO WEBSITE. THOSE INTRODUCTORY THINGS, A LOT OF SITES USED THEM IN WAITING ROOMS TO PREPARE PATIENTS. DUE TO REGULATORY REQUIREMENTS IN A CONSENT, THEY'RE NOT LESS THAN. THE SHORTEST I HAVE SEEN WITH OUR LAST EFFORTS MIGHT HAVE BEEN 10 TO 12 PAGES. BUT THE CONVERSATION IS MUCH MORE IMPORTANT WITH THE PATIENT THAN ESSENTIALLY THAT PIECE OF PAPER. BUT WE HAVE TO HAVE THEM. IT'S PART OF OUR PROCESS. AND I DO THINK YOU CAN AS A NURSE WHO USED TO SIT DOWN AND GO OVER THESE WITH PATIENTS I WOULD WALK THROUGH EACH CONSENT AND THAT'S PART OF WHAT WE HAVE TO DO. >> I IMAGINE THIS IS SOMETHING WE CAN AGREE ON, WISH THEY WERE SHORTER. >> AGREE. >> I APPRECIATE YOUR COMMENT ABOUT AS I UNDERSTAND WHAT YOU JUST SAID, WHAT'S ALL WRITTEN IS A COMPONENT OF THE INFORMED CONCEPT BUT NOT THE TOTALITY. I WAS TRAINED IN THE HARVARD SYSTEM AND IN HARVARD THERE'S A GUIDE ABOUT THIS. ONE QUICK EXAMPLE IS IT'S REALLY THE DOCTOR WHO UNDERSTANDS THE ALTERNATIVE THERAPIES AVAILABLE SO WE IN INDUSTRY, WE CAN'T THINK OF WRITING OUT A LIST OF ALTERNATIVE THERAPIES, YOU'RE SUPPOSED TO TELL THE PATIENT. IT'S REALLY THE BEDSIDE ASSESSMENT OF THAT DOCTORS RESPONSIBILITY TO OR THE NURSE PRACTITIONER, TO HELP THE PATIENT UNDERSTAND WHAT ALTERNATIVES. SO ONE EXAMPLE I THINK I HOPE WE AGREE, WHATEVER IS WRITTEN IN THE DOCUMENT IS JUST WE HAVE TO APPRECIATE AS COMPONENT OF THE INFORMED CONSENT AND NOT THE TOTALITY. >> IT'S PART OF THE PROCESS. >> LAST TOPIC IS NATIONAL CLINICAL TRIALS ANALYSIS. >> QUESTION ON INFORMED CONSENT IF I MAY. >> THIS IS A VERY GRANULAR QUESTION BUT HAS THERE BEEN ANY TRANSLATION OF THE NEW INFORMED CONSENT TEMPLATE PREPARED OR ANY PLANS TO CREATE A SPANISH TRANSLATION OR OTHER LANGUAGE TRANSLATION? >> WHAT WE DO FOR OUR NCTN TRIALS IS WE TRANSLATE CONCEPT FOR PROTOCOL. BECAUSE THE TEMPLATE, I DON'T KNOW IF YOU HAVE SEEN IT, PEOPLE WANTED SO MANY DIFFERENT EXAMPLES OF THINGS THAT THAT WOULD BE JUST HUGE EFFORT. SO WE DO IT AT THE PROTOCOL LEVEL SO FOR ALL OF OUR LARGE TRIALS THEY ARE TRANSLATED INTO SPANISH. BUT THAT'S THE ONLY LANGUAGE WE HAVE THE RESOURCES TO DO. >> ANY COMMENTS ON THE THIRD TOPIC? PLEASE. >> THIS CAME UP A WEEK OR SO AGO AT THE AACI BOARD OF DIRECTORS MEETING. THE PAYMENT SYSTEM IS MOVING TOWARDS BUNDLE PAYMENTS FOR PATIENTS. AS THEY COME IN. EVEN THOUGH THINK MAYBE QUOTE STANDARD TESTS, THERE IS INCREASING PRESSURE TO MINIMIZE TESTING DONE ON. SO THIS IS REALLY INCREDIBLY IMPORTANT ISSUE. AND WILL ONLY BECOME MORE IMPORTANT ADS TIME GOES ON. DO WE NEED A CAT SCAN OR PET SCAN EF SIX WEEKS OPPOSED TO EVERY 12 WEEKS. SUBTLE THING, STILL CONSIDERED STANDARD OF CARE BUT ONE MAYBE MORE ACCEPTABLE. >> I AGREE, I WAS ON THE A PANEL WITH AACI CLINICAL RESEARCH INITIATIVE THIS SUMMER THAT TALKED ABOUT THIS ISSUE AND THE HANDS THAT WENT UP FROM EVERY CANCER CENTER ABOUT THIS BEING A CHALLENGE, I HEARD IT LOUD AND CLEAR. >> JANET, LAST WORD. >> I'M WONDERING IF IN THE PROCESS OF DOING THE ANALYSIS IF THE RESULTS ARE FED BACK BEFORE THE PROTOCOL IS FINALIZED OR IS IT DONE AFTER THE PROTOCOL IS FINALIZED? >> GREAT QUESTION. WHEN WE STARTED THE PILOT WE WERE DOING AT THE END. WE LEARN QUICKLY THAT WAS THE WRONG TIME TO DO IT. LOTS OF THIS DOESN'T GET COVERED IN SO NOW IT'S STARTING EARLY SO NOW GETTING CALLS EARLY FROM INVESTIGATORS, WHAT ABOUT THIS, BECAUSE THE BIOMARKERS ISSUES SUCH A MOVING TARGET. SO THAT'S REALLY GOING TO -- THAT'S EVOLVING RAPIDLY, WHAT'S COVERED, WHAT'S NOT. WHERE WE CAN GET ADDITIONAL FUNDING TO HELP WITH THOSE PAYMENTS, VERSUS WHAT'S REALLY COVERED. SO WE'RE NOW OUR PROCESS HAS CHANGED. AND WE OOHER NOW DOING IT AT THE FIRST PROT CONTROL SUN MISSION. >> I THINK THAT'S GREAT. >> REALLY WALLY IS GOING TO HAVE THE LAST WORD. >> ANDREA, GREAT WORK. ON THE COVERAGE NAIL SHY, ARE YOU AND OTHERS LEARNING WHETHER JUST DO US THE COVERAGE ANALYSIS DEFINING WHAT YOU THINK SHOULD BE COVERED IS HELPING DEFINE A PATTERN OF STANDARDS THAT PERHAPS NO OTHER ENTITY AROUND IS DOING? AND THEREFORE PROVIDING GREATER CLARITY FOR PAYERS IN FUTURE TRIALS? >> I DO. AN AREA THAT'S A CHALLENGE, IS SOME OF OUR RARE DISEASES AND SOME TUMORS SOME PEDIATRICS DON'T HAVE WELL DEFINED NATIONAL GUIDELINES. SITES WANT TO HAVE A PEER REVIEW DOCUMENT SOME SOURCE TO SAY, CHALLENGE BY MEDICAID MEDICARE THIS IS A STANDARD. THAT IS WHERE WE NEED TO COLLABORATE WITH INVESTIGATOR IT IS TEAM AT CTSU DOING THESE, DON'T HAVE THE EXPERTISE IN THESE. WE HAVE INTERNIST LEADING THE TEAM AND NURSES, SEW WE NEED HELP FROM INVESTIGATORS TO SAY THIS IS WHY THIS IS NEEDED IN THIS CANCER AND WE SITE THE LITERATURE IN THESE NATIONAL COVERAGE ANALYSIS. SO THAT CANCER CENTERS AND COMMUNITY SITES CAN FEEL LIKE THEY HAVE THEIR HAT TO HANG ON IF AUDITED BY WHATEVER, THEY HAVE DONE THEIR DUE DILIGENCE BY SAYING WE HAVE SUPPORTIVE EVIDENCE TO DO THAT. SO I DO THINK THIS WILL HELP EVERYBODY. >> THANKS VERY MUCH, WONDERFUL REPORT. VERY IMPORTANT TOPICS. WE'RE GOING TO MOVE TO ANOTHER TOPIC IN THE CLINICAL TRIALS SPACE, THE NCI IMPLEMENTATION OF THE NIH CLINICAL TRIALS STEWARDSHIP POLICIES. WE ARE FORTUNATE THAT LORI LENDER SEN IN THE DIVISION OF CANCER TREATMENT AND -- HENDERSON WILL LEAD US THROUGH THIS DISCUSSION TODAY. WHILE SHE'S COMING UP TO THE PODIUM, OUR JOB IS TO PROVIDE FEEDBACK SO WE ASK FOR THOUGHTS HOW TO COMMUNICATE THESE POLICIES TO THE CANCER RESEARCH COMMUNITY. >> THERE'S A SLIGHT CHANGE IN THE PRESENTATION AS A RESULT OF RECENT CLARIFICATION ONE OF THE POLICY SO I WANT TO BE CERTAIN I HAD INCORPORATED THAT IN PRESENTATION TODAY. >> THANK YOU VERY MUCH FOR THIS OPPORTUNITY TO PRESENT TO YOU SOME OF THE ACTIVITIES UNDERTAKEN AND ARE CONTINUING TO PROCEED WITH REGARDS TO IMPLEMENTATION OF THE NEW NIH CLINICAL TRIAL POLICIES. THIS IS IN REFERENCE TO WORK THROUGH OFFICE OF EXTRAMURAL RESEARCH I SERVE AS NCI REPRESENTATIVE ON THE CLINICAL TRIALS OPERATION WORK GROUP AS WELL AS CHAIRING, CO-CHAIRING THE STEWARDSHIP COMMITTEE THAT NCI HAS SPECIFICALLY. IN COLLABORATION WITH DICK DIPKIN. WE WERE DOING THIS UNDER THE GUIDANCE OF DR. ABRAMS. TODAY'S PRESENTATION IS REALLY GOING TO BE TWO FEOFFMENT FIRST TO GIVE AN UNDERSTANDING OF WHAT STEWARDSHIP MEANS TO THE NIH. WHAT THE GOALS ARE. WHAT ARE THE POLICIES. POLICIES ARE TWO FOLD. FIRST POLICIES PERTAIN TO HUMAN SUBJECTS. THEN ADDITIONAL POLICIES THAT REFLECT CLINICAL TRIALS UPDATES. THEN IN THE SECOND HALF I'LL TALK ABOUT THOSE SPECIFIC ACTIVITIES THE NCI AND VARIOUS WORK GROUPS WE HAVE INCORPORATED IN TERMS OF NOT JUST IMPLEMENTATION BUT COMMUNICATIONS OF THE CHANGES IN POLICIES. DURING THE LAST TWO YEARS, THE OFFICE OF EXTRAMURAL RESEARCH HAS MADE SIGNIFICANT PROGRESS IN TRYING TO DEVELOP NOT ONLY POLICIES BUT THE IMPLEMENTATION OF THOSE POLICIES. BUT ONLY REFLECTIVE OF FIRST WAVE OF REFORMS. AND THAT BEGAN AS EARLY AS 2012 WHEN THE NIH ACTUALLY ASSESSED THE -- WAS ASKED TO ASSESS THE APPLICABILITY OF THE IOM REPORT RECOMMENDATIONS THAT WAS -- THAT WAS ESTABLISHED BY THE CLINICAL TRIALS SUPPORTED BY NCI. AT THIS TIME IT WAS DETERMINED THAT THESE POLICIES WOULDN'T NECESSARILY BE READILY APPLICABLE TO ALL THE ICs BECAUSE OF VARIATIONS IN RESEARCH AND MANY OTHER ASPECTS. ANALYSIS IN GENERAL WAS NOT COMPLETE ENOUGH TO GO FORWARD WITH THOSE RECOMMENDATIONS. HOWEVER IN 2013 WHEN REPORTING TO CONGRESS THE NIH CAME ONE THEIR OWN RECOMMENDATIONS. THESE RECOMMENDATIONS ARE FOCUSED ON ESTABLISHING STEWARDSHIP INITIATIVE. THIS WAS DONE AT CLINICAL TRIALS WORK GROUP THAT WAS FORMED TO DEVELOP EIGHT RECOMMENDATIONS THAT FOCUS ON STEWARDSHIP. IN 2015, A TASK FORCE WAS FORMED TO DEVELOP A POLICIES AROUND THOSE RECOMMENDATIONS. IN ADDITION THERE WAS A GAO REPORT THAT LOOKED AT WHAT NIH HAS DONE RELATIVE TO THE IOM RECOMMENDATIONS. AND FROM THAT REPORT, THERE WAS STRONG RECOMMENDATION TO FOCUS ON CLINICAL TRIALS DATA COLLECTION AND IMPLEMENTATION OF THAT DATA FOR USE. THEN MOST RECENTLY TO IMPLEMENT THESE POLICIES, THERE ARE TWO COMMITTEES FORKED. FIRST AS I MENTIONED PREVIOUSLY INTERIC CLINICAL TRIALS OPERATIONAL WORK GROUP BEING LED BY DR. SHERRI MILLS AT THE OFFICE OF EXTRA EXTRAMURAL PROGRAMS AND THE SECOND IS SPECIFIC STEWARDSHIP COMMITTEE, SO THAT TASK -- WHAT I'LL FOCUS ON FOR THE REMAINDER OF THIS PRESENTATION IS WHAT IS OCCURRED OVER THE PAST -- SINCE 2015. SO TO ACHIEVE THE STEWARDSHIP GOALS THERE WERE A NUMBER OF THINGS THAT HAD TO BE AGREESED. AND CHALLENGE IS FOCUSED ON LOOKING AT DESIGN OF THE TRIALS, EFFICIENCY AND REPORTING OF THE CLINICAL TRIALS. MUCH OF THAT INFORMATION IS AVAILABLE TO PARTICULAR PUBLICATIONS. FIRST IS VIEW POINTs SHADE AUTHORED BY DR. FRANCIS COLLINS AND IS AVAILABLE IN JAMA. THE SECOND IS TALKING ABOUT FINAL RULE AND RUERING RELATIVE TO THAT. -- REPORTING RELATIVE TO THAT. BOTH ARE INFORMATIVE AND I BELIEVE WE HAVE THEM BOTH IN YOUR HANDS BOOKS IF YOU WISH TO LOOK AT THEM BUT YOU WILL FIND MORE DETAILS AS TO WHAT ENTAILS THE FIRST WAVE OF REFORM, WHAT IS BEING TARGETED. SO I ENCOURAGE YOU TO REVIEW THAT FOR INFORMATION. THERE ARE SIX MOST RELEVANT POLICIES TO CONSIDER THINKING ABOUT CLINICAL TRIALS RESEARCH. THERE ARE OTHERS THAT SPUN OFF FROM THESE PRIMARY POLICIES THAT I WON'T TALK ABOUT TODAY SO IT'S IMPORTANT TO GO IN AND REVIEW THE VARIOUS POLICIES TO GET THAT ADDED INFORMATION. AMONG THE POLICIES THERE'S ONE THAT IS DEVELOPING NEW TRAINING, NEW TRAINING PROGRAM. OTHERS ON IMPROVING THE APPLICATION PROCESS AS WELL AS INCREASING ABILITY TO ASSESS THE MERITS OF REVIEW APPLICATIONS FEASIBILITY THROUGH THE APPLICATION PROCESS. SO YOU'LL GO THROUGH QUICKLY TO GIVE YOU AN UNDERSTANDING OF THE BASIC KEY POINTS RELATIVE TO THAT. THESE POLICIES DO INDEED REFLECT LIFE CYCLE OF THE CLINICAL TRIALS. THAT BEGINS FROM THE DEVELOPING FUNDING OPPORTUNITIES ANNOUNCEMENTS THAT I ALLOW APPLICANTS TO SUBMIT THEIR PROPOSALS. WITH IMPROVEMENTS IN REVIEW PROCESS THROUGH MONITORING THE CLINICAL TRIALS ONCE AWARD IS MADE AND ENSURING THAT THE RESULTS OF THOSE TRIALS ARE REPORTED SO THE PUBLIC IS AWARE OF WHAT IS DONE IN REFERENCE TO THE TRIALS. THE EVENT IS TO IMPROVE THE SCIENTIFIC RIGOR, TRANSPARENCIES AND THE ETHICAL OVERSIGHT AFFILIATED WITH THE POLICIES. FOR DOING HUMAN SUBJECTS RESEARCH, THERE'S TWO PARTICULAR POLICY CHANGES, ONE IS A SINGLE IRB THAT APPLIES FOR MULTI-SITE STUDIES. THIS IS FOR ALL HUMAN SUBJECTS RESEARCH AND OTHER IS APPLICATION FORMS THAT IMPACTS WHAT ONE HAS TO KNOW AT THE TIME SUBMITTING APPLICATION BECAUSE OF ADDITIONAL INFORMATION COLLECTED THROUGHOUT THE ENTIRE PROCESS. AND I WILL TALK ABOUT TWO PARTICULAR FORMS. FIRST IS REFERRED TO AS THE PHS HUMAN SUBJECTS CLINICAL TRIAL FORMS. THE OTHER IS PART OF A NEW APPLICATION PACKAGE THAT BRINGS IN ADDITIONAL CHANGES TO HOW ONE GOES THROUGH AND SUBMITTING THEIR APPLICATION. FIRST LET'S FOCUS MORE ON THE SINGLE INSTITUTIONAL REVIEW BOARDS BEING REQUESTED. ALL REQUESTED MULTI-SITE STUDIES IS EXPECTEDDED TO CRUISE THE SINGLE I, AREB FOR ETHICAL REVIEW. THIS IS NONEXEMPT HUMAN SUBJECTS RESEARCH PROTOCOLS. THE APPLICATION ITSELF MUST INCLUDE A PLAN THAT DESCRIBES TWO PARTICULAR THINGS. THE USE OF THE SINGLE IRB, CONFIRMATION USING THE SINGLE IRB AND WHO IS TO SERVE AS IRB OF RECORD. IN ADDITION TO THAT, THERE'S EXPLANATIONS AS TO HOW YOU'RE COMMUNICATING BETWEEN THE SITES, AND SINGLE IRB. FOR ADOPTION, THE NIH ACTUALLY HAS CREATED STANDARDIZED AGREEMENTS, AND IT WILL ALLOW INSTITUTIONS TO RELY ON SINGLE IRB PROCESS. THERE ARE FORMS IN A LAR PLATFORM DEVELOPED AT REFERRED TO AS SMART. THIS IS HOUSED WITHIN NCATS WHICH IS OUR NATIONAL CENTER FOR ADVANCING TRANSLATIONAL SCIENCE IN THE INFORMATION IF YOU'RE INTERESTED IN LEARNING MORE ABOUT WHAT THAT ENTAILS. IT IS AVAILABLE ON THEIR WEBSITE. FOR FURTHER REVIEW. I THINK IT'S IMPORTANT THE PAY ATTENTION TO THIS PARTICULAR POLCY OR NOTICE BECAUSE THERE ARE EXCEPTIONS TO THE RULE. ONE PART IS THERE'S A WAIVER DEPENDING ON WHAT THE CIRCUMSTANCES ARE. SO LET'S FOCUS MORE ON APPLICATION PROCESS, THIS IS THE MOST PROMINENT CHANGE WITHIN THE SERIES OF POLICIES THAT HAVE BEEN IMPLEMENTED. AND THAT IS, THERE'S A FORM THAT I MENTIONED, IT'S THE HUMAN SUBJECTS AND CLINICAL TRIALS INFORMATION FORM. AND WHAT THAT DOES IS IT COMPILES ALL THE INFORMATION THAT'S NORMALLY COLLECT FOR HUMAN SUBJECTS ALONG WITH ADDITIONAL INFORMATION ON CLINICAL TRIALS IN ONE PLACE. AND IT IS INCLUDED IN THE APPLICATION PACKET SO YOU WILL FIND IT IN TERMS OF WHAT WE FIND FORM E APPLICATION GUIDE. IT ALSO INCLUDES A TOOL TO THEMSELVE RESEARCHERS DETERMINE WHETHER OR NOT THEIR RESEARCH OR THEIR STUDY IS INDEED AN NIH DEFINED CLINICAL TRIAL. AND THAT IS REFERRED TO AS CLINICAL TRIALS QUESTIONNAIRE. NOW, IT'S IMPORTANT THAT YOU FOLLOW THROUGH, AND AGAIN, YOU HAVE NO OPTION IF YOU OOHER GOING THROUGH SUBMITTING YOUR APPLICATION ONLINE THROUGH THE GRANTS.GOV PROCESS, TO DETERMINE WHETHER OR NOT IT IS INDEED A CLINICAL TRIAL, AND TO DO THAT THERE ARE FOUR QUESTIONS THAT HAVE ASKED, THE FIRST IS DOES THE STUDY INVOLVE ONE OR MORE HUMAN SUBJECTS? IS IT PROSPEC TVLY ASSIGNED, HUMAN SUBJECTS TO THE INTERVENTION? DOES THE STUDY EVALUATE EFFECT OF THE INTERVENTION ON THE HUMAN SUBJECTS? DOES STUDY HAVE BIOBEHAVIORAL OR BEHAVIORAL OUTCOME? IF PLAIN CAN'T SAYS YES THEN IT IS DEFINED AS A CLINICAL TRIAL. IT'S IMPORTANT TO GO THROUGH THAT EXERCISE BECAUSE THERE DICTATES WHAT YOU DO IN TERMS OF YOUR PROPOSAL YOU'RE WRITING. SO YOU NOW BECAUSE OF THE NEW FUNDING OPPORTUNITIES ANNOUNCEMENTS, POLICIES, WHICH I WILL GET INTO LATER, YOU HAVE TO APPLY TO THE APPROPRIATE ONE SO YOU HAVE TO KNOW WHICH IS APPROPRIATE. WHICH IS NOT SO IT HELPS IN THAT SELECTION PROCESS. IT ALSO HELPS DETERMINE HOW DO YOU WRITE RESEARCH STRATEGY SECTION OF YOUR PROPOSAL BECAUSE NOW THERE'S INFORMATION THAT WE WOULD STANDARD -- SEE AS STANDARD WITHIN THE RESEARCH STRATEGY SUCH AS STATISTICAL PLAN REMOVEDED FROM THE RESEARCH STRATEGY SECTION, ATTACHMENT IN THE FORM. SO YOU HAVE TO DELINEATE WHAT'S GOING TO BE IMPORTANT IN TERMS OF RESEARCH STRATEGY WHICH REALLY FOCUSES ON THE RATIONALE FOR THE STUDY AND MANY OTHER ASPECTS. AND THEN IT ALSO ENSURES THAT YOU'RE COMPLYING WITH THE APPROPRIATE POLICIES. IT IS IMPORTANT TO UNDERSTAND THE QUESTIONNAIRE AND BE ABLE TO DO THIS IN ADVANCE OF THE TIME OF YOUR SUBMISSION. THERE ARE ALSO FOUR ADDITIONAL POLICIES THAT PERTAIN TO CLINICAL TRIALS. AS MENTIONED BEFORE, THE NEW TRAINING ON GOOD CLINICAL PRACTICE, IMPLEMENTED AND EFFECTIVE AS OF JANUARY 1st THIS YEAR. THERE'S A CLINICAL TRIALS SPECIFIC OPPORTUNITY FUNDING ANNOUNCEMENT. NEW REVIEW CRITERIA FUNDED OPPORTUNITY ANNOUNCEMENTS AND EXPANDED REGISTRATION AND RESULTS REPORTENING CLINICALTRIALS.GOV. I WILL TOUCH ON EACH BRIEFLY. THE GOOD CLINICAL PRACTICE APPLIES TO ALL NIH FUNDED INVESTIGATORS. AS WELL AS ALL NIH STAFF THAT ARE INVOLVED IN THE CONDUCT. OVERSIGHT OR MANAGEMENT OF CLINICAL TRIALS. THE GOOD CLINICAL PRACTICE YOU'RE EXPECTED TO RECEIVE TRAINING THAT IS CONSISTENT WOMEN THE INTERNATIONAL CONFERENCE ON HARMONIZATION AND FOLLOWING THE CURRENT E-6.2 GUIDELINES AND PRINCIPLES. IT IS INTENDED TO EPIENSURE THE SAFETY INTEGRITY AND QUALITY OF CLINICAL TRIALS, THERE ARE MANY DIFFERENT WAYS WHICH YOU CAN RECEIVE THAT TRAINING. THERE'S SPECIFIC COURSES, CLASSES, THERE'S NO SPECIFIC RECOMMENDATION FROM NIH OR NCI AS TO WHAT SHOULD BE CONSIDERED APPROPRIATE BUT THERE ARE TWO COURSES THAT ARE FREE THAT CAN BE TAKEN AND THAT IS THROUGH THE NIAID, INFECTIOUS DISEASE INSTITUTE AND THE DRUG INSTITUTE AND THEN ALSO OFFERS THE COURSE AND'S A COMMERCIALLY BASED Z WHERE TAYLOR MODULES ACCORDING TO THE TRAINING YOU WOULD LAKE TO HAVE BUT REQUIRES A SUBSCRIPTION. NEXT IS THE POLICY THAT THERE ARE ALL CLINICAL TRIAL APPLICATIONS MUST BE SUBMITTED TO FUNDING OPPORTUNITY ANNOUNCEMENT THAT ALLOWS CLINICAL TRIALS. THE IMPORTANCE OF THIS IS THAT THEY'RE NOW SPECIFIC INFORMATION INCORPORATED IN THOSE ANNOUNCEMENTS THAT ONE HAS TO COMPLETE AND COMPLY TO. EACH FUNDING OPPORTUNITY ANNOUNCEMENTS AS CREATED CAN BE DESIGNATED IN DIFFERENT WAYS. IF YOU'RE DOING A FUNDING OPPORTUNITY ANNOUNCEMENT, WHERE CLINICAL TRIALS IS NOT PART OF THE RESEARCH SCOPE, THEN IT WOULD BE DESIGNATED AS A CLINICAL TRIAL NOT ALLOWED. IF YOU'RE DEALING WITH A RESEARCH THAT'S CONSIDERED THE OPTION OF WHETHER OR NOT TO DO COMPLETELY BASIC RESEARCH OR PRE-CLINICAL STUDIES, AND AT THE SAME TIME POSSIBILITIES SIZE MAY DICTATE THE INCLUSION OF CLINICAL TRIALS ONE USE THE CLINICAL TRIALS OPTIONAL. CATEGORY. YOU HAVE THE OPTION TO DESIGNATE AS CLINICAL TRIALS REQUIRED MEANS THAT YOU HAVE TO SUBMIT PROTOCOL AWE FILLIATED WITH THAT -- AFFILIATED WITH THAT ANNOUNCEMENT. AND THERE'S A SPECIFIC CATEGORY FOR GRANTS WHERE MENTORING IS THE PURPOSE OF THE APPLICATION IN THAT CASE, THEY ARE NOT ALLOWED TO DO UNDERSTOOD IF PEN DEBIT CLINICAL TRIALS SO -- INDEPENDENT CLINICAL TRIALS SO TAKING COMPLETE OWNERSHIP IN WHICH TO DO RESEARCH AFFILIATED WITH THAT. SO AS FAR AS THE REVIEW CRITERIA , NEW REVIEW CRITERIA THE SCIENTIFIC REVIEW OF APPLICATION. IN ADDITION TO THAT, THERE IS ANOTHER CATEGORY THAT LOOKS AT THE STUDY TIME LINE. ALL THESE QUESTIONS PART OF THE EVALUATION PROCESS. TO FURTHER INFORM APPLICANT HOW TO DEAL WITH THE INFORMATION THAT NEEDS TO BE COLLECTED THEREAFTER. THEN THE LAST IS ON DISSEMINATION OF NIH FUNDED CLINICAL TRIALS INFORMATION. THIS IS IN REFERENCE TO REGISTERING REPORTING NEW CLINICAL TRIALS. YOUR CLINICAL TRIAL IN CLINICALTRIALS.GOV. ALL INVESTIGATORS WHETHER THEY'RE FUNDED IN WHOLE OR BY PART, REGARDLESS OF TYPE OF FACE OF TYPE OF TRIAL HAS TO REGISTER TRIAL 21 DAYS OF THE FIRST PATIENT ENROLLED. AS FAR AS REPORTING RESULTS, IT WAS REQUIRED IT'S DONE NO LATER THAN ONE YEAR AFTER THE TRIALS PRIMARY COMPLETION DATE IS ACHIEVED. THE INTENT AS MENTIONED PREVIOUSLY IS TO ENSURE THE TRANSPARENCY AND RESEARCH AND ENSURING THAT FURTHER RESEARCH CAN BE DONE BASED ON RESULTS GENERATED. SO THE LAST PART TO IF CUSS MORE ON THE -- FOCUS MORE ON ACTIVITIES THAT WE DO WITHIN NCI IN PARTICULAR, IN 2016 NCI LAUNCHED AN INSTITUTE WIDE EFFORT TO ACHIEVE EFFICIENT OVERSIGHT AND MANAGEMENT ACROSS DIVISIONS OFFICES AND CENTERS FOR ENSURING THAT WE HAVE THE QUALITY OF THE CLINICAL TRIAL, THE SAFETY OF THE RESEARCH PARTICIPANTS, THE RELIABILITY OF THE DATA, AND THE APPROPRIATE STEWARDSHIP OF FUNDS. SO THIS IS THE GOAL AND THE VISION FOR WHAT YOU'RE GOING FORWARD BASED ON DIFFERENT ACTIVITIES. WE SELECTED THREE DIFFERENT PLANNING GROUPS, EACH HAVING THEIR OWN PARTICULAR ACTIVITIES OFFER TASKS THE ACHIEVE, AND THIS IS TO HELP WORK THROUGH IMPLEMENTATION PROCESS. FIRST MENTIONED BEFORE THE OPERATIONS WORK GROUP. WE HAVE MANY NCI STAFF THAT SERVE TO HELP ON THE VARY YOU SUBCOMMITTEES TO DEAL WITH CHALLENGES AND HURDLES THAT COME UP IN THINKING ABOUT IMPLEMENTATION AND POLICIES. THIS RANGED FROM DEVELOPING TRAINING MATERIALS WHICH TO DO SO. ALL THE WAY THROUGH BEING ABLE TO DEVELOP TOOLS FOR THE MANAGEMENT OF CLINICAL TRIALS. THE STEWARDSHIP COMMITTEE, IT IS A -- CONSISTS OF REPRESENTATIVES ACROSS THE NCI FROM THE VARIOUS DIVISIONS OFFICES AND CENTERS. IT GUIDES DEVELOPMENT OF OUR SPECIFIC INITIATIVES SO IT'S EVOLVING PROCESS WITH RESPECT ADDITIONAL ACTIVITIES ARE INCORPORATED AS NEEDED. THEN THE PRIMARY OBJECTIVE WE HAVE HAD IS TO CREATE A SET OF STANDARD OPERATING PROCEDURES, FOR THE OVERSIGHT OF CLINICAL TRIALS AND AWARDS. THESE AWARDS WE'RE REFERRING TO BOTH GRANTS COOP RA TESTIFY AGREEMENTS AND CLINICAL TRIALS. AND THE THIRD GROUP IS OUR COMMUNICATION OFFICE WHICH IS TRACKING ALL THE DIFFERENT THINGS THAT ARE COMING OUT FROM THE -- FROM THIS INITIATIVE. THE NIH WIDE INITIATIVE. AND COMMUNICATING THAT NOT JUST TO STAFF BUT EXTRAMURAL COMMUNITY OUR OWN EXTRAMURAL COMMUNITY. PART OF THAT IS WE'RE DEVELOPING TRAINING MATERIALS FOR NEW EMPLOYEES AS THEY ENTER THROUGH THE ORIENTATION PROGRAM. RECEIVE FIRST THING WE SET TO DO IS SIGNIFICANT ACCOMPLISHMENT IS DEVELOPING THE APPROPRIATE NCI SPECIFIC FOAs. THERE ARE 32 THAT INVOLVE CLINICAL TRIALS. BUT IS IMPORTANT TO NOTE THAT NCI DECIDED NOT TO PARTICIPATE IN THE NIH CLINICAL TRIALS REQUIRED PARENT RO1 AND R-21. THE NIH WILL CONTINUE WITH THE HISTORIC RO1 FOR NON-CLINICAL TRIAL RESEARCH AND PRODUCING ANOTHER OPPORTUNITY ANNOUNCEMENT THAT REQUIRES CLINICAL TRIALS. WE ARE NOT PARTICIPATING ON THAT. WE HAVE DEVELOPED TWO OF OUR OWN. IN PARTICULAR THE INVESTIGATOR INITIATED CLINICAL TRIALS FOR DIVISION OF CANCER AND TREATMENT -- CANCER AND TREATMENT DIAGNOSIS, A SECOND FUNDING OPPORTUNITY ANNOUNCEMENT JOINT SOLICITATION BETWEEN DCP AND DCCPS. WE ARE -- WE HAVE REISSUED OUR R-21 AS CLINICAL TRIALS OPTIONAL AND THE RO 3 WILL ALSO BE REISSUED AS CLINICAL TRIAL OPTIONAL. IF YOU NOTICE, TALK ABOUT THE SPORES, THE SPORES ARE NOW GOING TO REQUIRE CLINICAL TRIALS WHEN THEY SUBMIT APPLICATION. SO THESE ARE A FEW EXAMPLES AMONG THE 34 THAT WE HAVEMENT SO I WOULD LIKE TO TALK MORE ABOUT WHAT WE'RE DOPPING IN TERMS OF TRYING TO -- DEVELOPING IN TERMS OF TRYING TO UNIFY PROGRAM OFFICER GRANTS MANAGEMENT REVIEWS, OF PROGRESS REPORTS. THIS IS FOCUSED ON ADVANCING PROJECT MANAGEMENT AND DOING IT THROUGH RISK ASSESSMENTS AND CLINICAL TRIAL MANAGEMENT PLANS. SO THE METHOD USED IS TO DEVELOP TOOLS BASED ON RISK-BASED APPROACH AND THAT ENCOMPASS DEFINING VARIOUS RISK ELEMENTS THAT PERTAINS TO FACETS FROM INTERVENTION TO CHARACTERISTICS OF A TRIAL TO WHETHER OR NOT A TRIAL THE READINESS OF THAT TRIAL. THE RISK CLASSIFICATION DETERMINES FREQUENCY AND MONITORING THAT WE ANTICIPATE APPLICANTS TO FOLLOW THROUGH ON AND MANAGEMENT PLAN TO FOCUS ON WHAT KEY ELEMENTS NEED TO BE FOCUSED ON IN MORE DETAIL AND WHAT INFORMATION WE COLLECT AS A RESULT OF THAT PARTICULAR RISK. SO THIS IS AN ACTIVITY TO FACILITATE TOOLS TO FACILITATE THAT PROCESS AND DOING A BETA TEST TO SEE HOW EFFECTIVE THEY ARE AND USABILITY AS WELL. IF OFFICE OF COMMUNICATION PUBLIC LIAISON HAS MADE EFFORTS INTO DEVELOPING RESOURCES FOR RESEARCHERS. THE NIH AUGUST # 1st -- AUGUST 11 PUT OUT NOTIFICATION TO BROADCAST NOTIFICATION TO VARIOUS RESEARCHERS ENFORMING OF CHANGES. THIS IS DONE THROUGH MIKE LAUR AND WHAT THE NCI IS FOCUSED ON IS DEVELOPING AN EMAIL STANDARDIZED EMAIL WITH NECESSARY KEY POINTS DISTRIBUTED THROUGH PROGRAM DIRECTORS AND OTHER MEANS. SO THERE WILL BE MORE BASED ON THAT AND WE'RE ALSO FOCUSING ON DEVELOPING A WEB PAGE THAT WOULD ENCOMPASS THE DETAILS. THAT IS MORE STRUCTURED AND ORGANIZED. THIS IS JUST AN EXAMPLE OF -- TO THE NIH IF YOU GO TO THIS PARTICULAR RESOURCE, IT LAYS OUT ALL POLICIES I TALKEDN'T AND GOES INTO INSTRUCTIONS HOW TO GO THROUGH THE APPLICATION PROCESS. WHAT WE HAVE DONE IN TERMS OF OUR IMMUNITY THAT ORGANIZES WHAT'S IMPORTANT FOR THE INVESTIGATOR, WHAT'S THE INITIATIVE ABOUT AND MANY OTHER DIFFERENT POINTS. TO REMEMBER. WITH THAT I WANT TO BRING FINAL ATTENTION TO KEY DATES TO KEEP IN MIND, ALL THIS GOES INTO AFFECT JANUARY 25th. RESOURCES AVAILABLE TO UNDERSTAND AND LEARN ABOUT THEM ARE NOW AVAILABLE. FOR EXAMPLE, THE APPLICATION FORMS, RELEASED PUBLICLY. ALONG WITH INSTRUCTIONS HOW TO APPLY GUIDE. AND THEN THE -- WE ANTICIPATE THAT ALL OF THE FUNDING OPPORTUNITY ANNOUNCEMENTS THAT INVOLVE CLINICAL TRIALS WILL BE RELEASED IN NOVEMBER. THE FIRST DUE DATE FOR APPLICATIONS THAT APPLY IS JANUARY 25th OF 2018. OF COURSE THAT SORT OF STARTS THE PROCESS FOR EVERYTHING, ALL THE CHANGES WE'LL DO IN TERMS OF MAKING AWARDS AND OVERSEEING MONITORING OF THOSE TRIALS. I WANT TO ACKNOWLEDGE THE FACT THAT THIS IS REALLY HAS BEEN A TRUE TEAM EFFORT THAT REQUIRE THE EXPERTISE ACROSS DIVISIONS OFFICES AND CENTERS AND ENSURE THAT THE OVERARCHING PROCEDURES ARE APPLICABLE. WE ARE IN THE PROCESS OF CONTINUING THOSE PER SIZES. WITH THAT, I THANK YOU FOR YOUR ATTENTION. >> THANKS VERY MUCH, LORI. COMPREHENSIVE REVIEW. ARE THERE COMMENTS, REMEMBER OUR CHARGE IS TO PROVIDE INFORMATION ON HOW WE CAN BETTER COMMUNICATE THESE POLICIES TO THE CANCER RESEARCH COMMUNITY. HOWARD THEN DAVID. >> I WOULD LIKE TO ASK HAVE THERE BEEN CONSIDERATIONS IN HOW TO ENGAGE SOCIALIZING THESE WITH LARGER WORLDWIDE INITIATIVES THAT ARE DOING SIMILAR THINGS? I THINK PARTICULARLY ICH E-8 CLINICAL TRIALS UNDERGOING REVISIONS, THERE'S A MEETING 2014 EXPERTS THEY INVITED PEOPLE TO PARTICIPATE SIMILAR TO MULTI-REGIONAL CLINICAL TRIALS MRCT GROUP. ALSO IS DOING SIMILAR WORK BUT MORE GLOBAL LEVEL BECAUSE WE SHARE TRIALS, THAT ARE DONE IN THE DATA FROM EXTERNAL TRIALS BECOME IMPORTANT FOR OUR DEVELOPMENT AND PRODUCT DEVELOPMENT IN THE U.S.. SO IT STRIKES ME THIS IS A TIMELY OPPORTUNITY FOR SHARING SOME OF THE CONCEPTS AND MAJOR DOMAINS THAT OTHER PEOPLE WANT TO LEARN FROM. >> THANK YOU VERY MUCH FOR THAT INPUT. ACTUALLY, I AM NOT AWARE OF NIH, NIH OD LEVEL PARTICIPATING IN THESE TYPE OF FORUMS. I DO KNOW FOLLOWING DIFFERENT THINGS IN TERMS OF REPORTS THAT COME OUT OF THE DIFFERENT TYPES OF SOCIETIES AND THERE IS SOMEBODY THAT FOLLOWS THROUGH ON ICH ACTIVITIES BUT I THINK THAT IS SOMETHING THAT CAN CERTAINLY TAKE BACK TO OUR GROUP AND INQUIRE MORE WHAT'S BEING DONE REGARDS TO THAT. THAT'S A GREAT OPPORTUNITY. >> >> THAT WAS A REALLY CLEAR PRESENTATION, I NOW UNDERSTAND THE SCOPE OF WORK YOU'RE DOING BESIDES TAKING CARE OF US FOR ALL THESE YEARS. I HAD A RELATIVELY SIMPLE QUESTION ABOUT THE PARENT RO1s. MY SIMPLISTIC IDEA IS THAT THERE ARE NOW RO1s FOR CLINICAL TRIAL OPTIONAL, WHERE REQUIRED BUT THE NCI HAS ITS OWN SPECIAL IMPLEMENTATION REQUIRED ONES OR DID IT GET THAT WRONG? >> THE NIH ONLY ONE RO1 PARENT ANNOUNCEMENT THAT NCI HAS, OWN SPECIFIC -- SEEMS TO BE RELEASED. THAT REQUIRES CLINICAL TRIALS. SO OUTSIDE THE INSTITUTE THERE ARE OTHERS, DEPENDS ON WHAT RESEARCH YOU'RE DOING BUT WE HAVE OURS IS CLINICAL TRIALS REQUIRED. >> IS THE BASIC PARENT RO1 CLINICAL TRIALS OPTIONAL? OR THIS HASN'T CHANGED -- >> THE NIH HAS ONLY TWO THAT THEY'RE PRODUCING. SOON TO BE RELEASED ONE THAT REQUIRES CLINICA TRIALS AND ONE THAT DOES NOT. THERE'S NO OPTIONS THERE. WE ARE PARTICIPATING IN OBVIOUSLY THE REQUIRED CLINICAL TRIALS BECAUSE WE ESTABLISHED OUR OWN, RELATIVE TO THE DIFFERENT PROGRAMS AND DECISIONS THAT WE HAVE SO MORE TO US CANNED TARGETED TO MEETING OUR -- FOCUSED AND TARGETED TO MEETING OUR MISSION SPECIFICALLY. >> QUICK QUESTION. SOME OF THE FIELDS YOU'RE REQUIRED IN YOUR CLINICAL TRIALS QUESTIONNAIRE SEEM TO BE DUPLICATIVE OF INFORMATION THAT'S IN CTRP AND CLINICALTRIALS.GOV. ARE DEFINITIONS MESHED WITH THE OTHER NIH REQUIREMENTS AND ANY EFFORTS TO LINK THEM SO WE DON'T HAVE TO SYNC THE INFORMATION MULTIPLE TIMES? >> I DO BELIEVE THEY'RE ONE MANY THE SAME. THEY ARE LINKED. THERE'S SOME ACTIVITIES THAT THE CTRP IS GATHERING ADDITIONAL INFORMATION WHAT NIH IS REQUIRING BUT THE DEFINITION ITSELF IS CONSISTENT WITH THE NCI REPORTING AND NIH. I WAS GOING TO LOOK AT -- PROGRAM SPECIFIC? >> MY UNDERSTANDING IS THAT EFFORTS HAVE BEEN MADE TO MAKE SURE THE ELEMENTS REQUIRED ON THE -- UNDER THE NEW POLICY AN THOSE REQUIRED FOR CLINICALTRIALS.GOV REGISTRATION ARE SIMILAR OR THE SAME. CTRP AND CLINICALTRIALS.GOV IS THE SAME. SO EFFORTS HAVE BEEN MADE THAT AT LEAST THE DEFINITIONS ARE COMPARABLE AMONG OTHER SYSTEMS AND WE'RE WORKING TOWARDS WORKING WITH THESE GROUPS TO MINIMIZE DUPLICATIVE DATA ENTRY THOUGH I THINK THOSE EFFORTS ARE STILL MADE. >> ANY OTHER COMMENTS? >> WELCOME QUESTION ABOUT SLIDE 15 WHERE YOU TALK ABOUT THE REVIEW CRITERIA FOR CLINICAL TRIALS. THESE WE WON'T SEE STILL JANUARY IN THE NEW RFAs THAT COME OUT. >> SO THE NOTICE DOES GIVE EXAMPLES OF THE QUESTIONS FOR EACH CATEGORY. SO -- >> NEW ADDITIONAL ONES IN LIGHT OF STEWARDSHIP POLICY. >> YES. YES. IF YOU GO TO THE NOTICE, THE REFERENCE NUMBER, GO BACK TO MY SLIDE. >> 117, 118. >> GO TO THAT PARTICULAR NOTICE IT WILL GIVE YOU THE EXAMPLE QUESTIONS RELATIVE TO EACH CATEGORY THERE. IF YOU LIKE TO SEE IN THE CONTEXT OF FULL FUNDING OPPORTUNITY ANNOUNCEMENTS, THERE ARE FEW THAT HAVE BEEN PUBLISHED. IF YOU CAN IN NOVEMBER MAY WANT TO USE THE RO1 EXAMPLE, THAT DETAILS INFORMATION. >> I HAVE TO STUDY BUT STUDY TIME LINE SEEMS LIKE THE JUDGMENT OF REVIEWERS AND I CAN'T EVEN IMAGINE A STUDY TIME LINE NOT BEING ACCEPTABLE. I'M WONDERING WHERE IS THE TEETH IN THAT CRITERION. >> THEY HAVE TO SAY IT'S UNETHICAL, GOING TOO LONG? I'M SORRY. EEL READ THE STUDY. >> I WAS GOING TO SAY THAT SHAMALA HERE IN OUR DEA OFFICE HAS BEEN PARTICIPATING IN COMMITTEE FOCUSED ON TRYING TO DEVELOP THE EDUCATIONAL MATERIALS FOR REVIEWERS TO ENTERFRET THOSE QUESTIONS. SO WE CAN LEARN MORE ONCE THE PROCESS IS COMPLETE. >> THANK YOU VERY MUCH. WONDERFUL PRESENTATION. WE'RE GOING TO TAKE A BREAK UNTIL 11 O'CLOCK ON THAT CLOCK UP THERE. IF YOU CAN COME BACK PROMPTLY BECAUSE WE WANT TO MAKE SURE THAT WE FINISH OUR NEXT TWO PRESENTATIONS BY THE TIME WE ARE VISITED BY DR. LOWY AND DR. DOROSHOW TO GIVE DEPUTY DIRECTORS UPDATES. THANKS. >> JIM TOLD ME I SHOULD BE USING MY GAVEL TO GET YOU GOING AGAIN. THERE WE GO. FIRST I HAVE BEEN TOLD THAT THOSE WHO ARE TRYING TO ALMOST TO US ON WEBCAST CANNOT HEAR US. SO AS A SPEAKER COULD YOU MAKE SURE YOU'RE CLOSE TO THE MIC AND EVERY QUESTIONER TURN ON YOUR MICROPHONE AND YOU'RE CLOSE TO IT BECAUSE THEY'RE NOT ABLE TO APPRECIATE THE IMPORTANT THINGS YOU'RE SAYING. WE HAVE AN HOUR, TWO IMPORTANT TOPICS. ONE HAS TO DO WITH THE N CORP RENEWAL AND THE SECOND IS WORK WE ASKED ABOUT ON THE VA WE WANT TO FINISH AT NOON BECAUSE WE HAVE DOUG COMING TO TALK WITH US. SO WITH THAT, WERTA WILL TALK WITH US IN HER CAPACITY AS CHIEF OF THE N CORE PROGRAM AND SHE WILL DESCRIBE THE NCI PLANS FOR RENEWING THE N CORP PROGRAM. VERY IMPORTANT THANK YOU. GOOD MORNING EVERYONE, I WILL PRESENT YOU YOU THE REPORT FROM THE EXECUTIVE COMMITTEE THAT REVIEWED MATERIALS FROM N CORE FOR REISSUANCE. >> YOU MIGHT BE ONE OF THE PEOPLE TALKING ABOUT HAVING TROUBLE HEARING YOU. I'M GOING TO PRESENT THE REPORT FROM THE EXTERNAL EVALUATION COMMITTEE FOR N CORE REISSUANCE SO I WILL PROVIDE -- N CORP. I'LL PROVIDE A SUMMARY PROVIDE RESPONSES FROM THE RECOMMENDATIONS AND PROPOSE SHARE WITH YOU PROPOSED MODIFICATIONS TO THE PROGRAM. I'M PRESENTING ON BEHALF OF THE DIVISION OF CANCER CONTROL AND POPULATION SCIENCES. DR. ANN GUYINGER AND HER TEAM ARE HERE TODAY. DIVISION OF CANCER TREATMENT AND DIAGNOSIS AND CENTER TO REDUCE CANCER HEALTH KISS -- DISPARITIES. AND N CORP HOUSE PREVENTION. N CORP LAUNCHED IN 2014 TO CONTINUE THE LEGACY OF PROVIDING ACCESS TO ADULTS AND CHILDREN IN THE COMMUNITIES IN WHICH THEY LIVE. WE HAVE A BROAD PORTFOLIO OF CLINICAL TRIALS, MUCH WHICH HAD BEGUN BUT IT WAS EXPANDED TO INCLUDE AND STIMULATE PREVENTION AND INCLUDES SYMPTOM SCIENCES SURVEILLANCE SCREENING AND QUALITY OF LOOF STUDIES EMBEDDED TO TREATMENT TRIALS. THE N CORP TREATMENT TRIALS AS WELL AS THOSE IN ADVANCE IMAGING, AND IT WAS AT A TIME WHERE WE UNDERSTOOD THAT THERE IS MUCH MORE TO QUALITY CARE COMMUNITY OTHER THAN PATIENTS SO CANCER CARE DELIVERY SEARCH CAME AS NEW COMPONENT OF THE N CORP TO DEVELOP PRACTICES THAT ACHIEVE OPTIMAL CLINICAL OUTCOMES. WE HAD A HISTORY OF ENROLLING UNDERSERVED POPULATIONS AND TO CLINICAL TRIALS OPPORTUNE TIME AS DIVERSE NETWORK TO SERVE AS LABORATORY TO HAVE RESEARCH QUESTIONS EMBEDDED INTO CLINICAL TRIALS AS WELL AS INTO CANCER CARE DELIVERY RESEARCH RESEARCH. WE ARE A LARGE NETWORK, WE HAVE OVER 4,000 INVESTIGATORS. AND ACTUALLY THE WORK FORCE INCREASE IN THAT INVESTIGATORS ACTUALLY HAVE INCREASED SINCE THE LAUNCH OF N CORP BY 120 INVESTIGATORS AND WE HAVE ADDED AUS ADDITIONAL 600 COMPONENTS AND SUBCOMPONENTS TO OUR PROGRAM AND THEY ARE AFFILIATED WITH 34 COMMUNITY SITES, 12 MINORITY UNDERSERVED SITES AND WE HAVE SEVEN RESEARCH BASES THAT ARE CHARGED TO DEVELOP THE CONCEPTS AND DATA MANAGEMENT FOR THOSE STUDIES. SO WE ADHERE TO NCI REQUIREMENTS FOR EXTERNAL EVALUATION PROGRAM FOR REISSUANCE AND ASKED THE QUESTION TO WHETHER OR NOT SCIENTIFIC CONTRIBUTIONS WERE SUFFICIENTLY SUPPORTED TO -- FOR REISSUANCE OF THE FUNDING OPPORTUNITY ANNOUNCEMENT AND WE ALSO ASK FOR BY RECOMMENDATIONS FOR ENHANCING THE SCIENTIFIC AND OPERATIONAL FUNCTIONS OF THE PROGRAM. WE CONVENED EVALUATION COMMITTEE OF NINE MENS LISTED HERE. THOSE IN RED ARE MEMBERS WHO PARTICIPATED IN THE EVALUATION OF THE NCTN, WE WANTED TO DO THAT FOR CONSISTENCY AND WE COMPRISED THIS GROUP TO COVER EXPERTISE WITHIN THE RESEARCH PORTFOLIO AND INCLUDED ADVOCATE AS WELL. THE FIRST QUESTION POSED TO TO EVALUATION COMMITTEE HAD TO DO WITH CLINICAL VALUE AND IMPACT OF THE PROGRA. THE COMMITTEE DID CONCLUDE THAT THE N CORP MADE IMPORTANT CONTRIBUTIONS IN TERMS OF SCIENTIFIC CLINICAL VALUE AND LISTED IN SIGHT OF THE FOLLOWING THE PROGRAM HAS BEEN IMPORTANT IN ADVANCING SYMPTOM SCIENCE, AND QUALITY OF LIFE STUDIES AND STIMULATING CANCER PREVENTION AND SCREENING AS WAS VERY IMPORTANT IDENTIFIED COMPONENT MOVING FORWARD TO THE PROGRAM, INTRODUCING THE SCIENCE OF OVERDIAGNOSESIS AND INVOLVING SCIENCE AN INCORPORATING INTO STUDIES. CONTRIBUTING TO THE NCTN NETWORK AND STIMULATING NEW INITIATIVES IN CANCER DISPARITIES RESEARCH. SO ONE OF THE RECOMMENDATIONS AND COMMENT MADE FROM THE COMMITTEE HAD TO DO WITH THE FOCUS OF THE SYMPTOM SCIENCE STEER COMMISSION. WE HAD TO RERATE THE STEERING -- REITERATE THE STEERING COMMITTEE IN 2008 IDENTIFIED SOME RESEARCH PRIORITIES. I HAVE LISTED IN OUR RESPONSE TO THAT, WE ACTUALLY HAVE 15 ACTIVE TRIALS WITHIN THOSE RESEARCH AREAS THAT HAD BEEN IDENTIFIED. THOSE AREAS INCLUDE CARDIOVASCULAR TOXICITY, COGNITIVE IMPAIRMENT, FATIGUE, CANCER SPECIFIC PAIN. WE ALSO HAD NEUROPATHY AREAS OF RESEARCH AND WE USE THE MECHANISM AVAILABLE TO US IN THE STEERING COMMITTEE, COMPONENT OF NCI TO HAVE A PLANNING MANY I WHICH ALLOWS YOU TO BRING EXPERTS TOGETHER TO DEVELOP A CONCEPT. AND THIS WAS QUITE APPROPRIATE BECAUSE THIS MIGHT BE SOMETHING THAT COULD BE ONE THAT COULD BE ACROSS RESEARCH ACTIVITY. THERE WAS A FURTHER COMMENT ABOUT INCAN US OF CORRELATIVE SCIENCE, WE THOUGHT IT WAS VERY IMPORTANT TO THINK ABOUT MECHANISMS OF THE SYMPTOM SCIENCE. PROGRAM WOULD LIKE TO REQUEST INCREASE FUNDING TO HELP TO INCLUDE SCIENCES TO ESTABLISH A BIOREPOSITORY. SO THAT WE CAN ADDRESS ISSUES OF PATIENT'S RESPONSE AND PREDICTING FACTOR THOSE PATIENTS HAVE SYMPTOMS RELATED TO CANCER TREATMENT AND AND TOXICITY. THE SECOND QUESTION RELATED TO THE SEARCH SUPPORT OF RESEARCH PORTFOLIO CONCLUDED THE INFRASTRUCTURE RESEARCH SITES COMMUNITY IN ADDITION THE INFRASTRUCTURE FORMED SUPPORTED BY NCI AND DATA COLLECTION SYSTEM AND PROGRAMMATIC INPUT FROM THE N CORP STAFF ADEQUATELY SUPPORTED THE PORTFOLIO. THEY NOTED THAT THE NETWORK REFLECTS THE SPECTRUM OF HEALTHCARE ENVIRONMENTS THROUGHOUT THE US. THAT THERE WAS STRONG ACCRUAL TO TREATMENT AND ADVANCE IMAGING TRIALS AS WELL AS TO CANCER CONTROL INTERVENTION AND THEY NOTED THAT THE ENROLLMENT AND ACCRUAL BETWEEN 2014 AND 2016 WAS ATTESTMENT TO SUCCESSFUL EFFORTS IN THIS AREA. IT WAS ALSO NOTED THERE WERE OTHER INFRASTRUCTURE CHANGES THAT HELP TO ADVANCE AND SUPPORT THE PROGRAM INCLUDING NEWLY DEVELOPED CENTRAL IRB FOR CANCER CONTROL. A CADRE OF WORKING GROUP, RADIATION ONCOLOGY GROUP BECAUSE WE MOVE FORWARD TO LOOK AT RADIATION TOXICITIES WE ARE SEEING IN OUR COMMUNITY HEIGHTENED MORE DEMANDS CREDENTIALING MORE WORK AT THE SITE LEVEL TO ENGAGE THE RADIATION ONCOLOGIST AND WE WANTED TO KNOW HOW BEST HAVE RADIATION ONCOLOGY INVOLVEMENT IN THE COMMUNITY SETTING. IT ALSO NOTED THE DISPARITIES INITIATIVE, THE ONE THAT WAS LISTED HERE HAS TO DO WITH SIX SOLID TUMORS IDENTIFIED TO HAVE SPECIFICALLY EARLY ONSET BURDEN RACIAL ETHNIC POPULATIONS THAT IS SPONSORED BY IMPORT AND CONDUCTED IN MINORITY UNDERSERVED SITES. I SHOW YOU ENROLLMENT OVER THIS PERIOD OF TIME, WE HAVE UPDATED THIS WAS THE CUT OFF DATE FOR THE MATERIALS THAT WAS SUPPLIED TO THE COMMITTEE WAS MADE, MARCH 31st. I CAN SHARE WITH YOU THAT UPDATING THE MATERIALS FOR THE THREE YEARS, THE TOTAL ENROLLMENT ACROSS CANCER CONTROL PRETENSION ADMITTED NEARLY 18,000 PATIENTS SO ON THIS SLIDE YOU SEE ENROLLMENT FOR CANCER CONTROL AS IT WAS PRESENTED TO THE COMMITTEE. I WANTED TO POINT OUT THAT THE PORTION OF THE ENROLLMENT IN CANCER CONTROL, IT'S IMPORTANT TO NOTE THAT THE EXPERTISE AND CONCEPTS COMING FROM THE PROGRAM, ALSO ALLOWED NON-N CORP SITES TO PARTICIPATE IN THIS VERY IMPORTANT RESEARCH. THIS SLIDE SHOW IT IS CONTRIBUTION AS MENTIONED EARLIER TODAY, OF N CORP TO TREATMENT TRIALS AND AVERAGES 30%. SO IN RESPONSE TO SOME OF THE COMMENTS FROM THE INFRASTRUCTURE SUPPORT RESEARCH PORTFOLIO, THERE'S A COMMENT ABOUT EXPANDING CANCER CARE DELIVERY RESEARCH INFRASTRUCTURE AT THE SITES. MY COLLEAGUES FROM UCPS ARE GOING TO REQUEST INCREASE FUNDING FOR THE IMPLEMENTATION AT THE SITE AND INCLUDING INFRASTRUCTURE OF CCGR. WHEN THE PROGRAM STARTED THERE WERE LIMITED NUMBER OF SITES. WE ASK IN THE RAF FOR AT LEAST A MINIMUM OF ONE SITE PARTICIPATING IN CANCER CARE DELIVERY RESEARCH. WE HAD 300 BUT WE INCLUDED ALL COMPONENT SITES ELIGIBLE TO PARTICIPATE IN THAT RESEARCH AREA. OPTIMIZE ADVOCATES AND COMMUNITY MEMBERS ACROSS THE NETWORK, LEGACY OF OUR PROGRAM THAT OUR SITES ARE SO DIVERSE THAT WE -- THE SITES HAVE A VERY STRONG CONNECTION WITH THE ADVOCACY COMMUNITY THAT'S APPROPRIATE FOR THEIR PARTICULAR CANCERS IN THEIR AREAS. AS WELL AS IN OTHER ORGANIZATIONS AND COMMUNITIES THAT SUPPORT THEIR PARTICULAR PROGRAMS. WE HAVE BEGUN NATIONAL DIALOGUE DIALOGUES, WE WILL BE REPRESENTED T AN ADVOCACY COMMITTEE MEETING IN DALLAS. THERE'S A COMMENT TO INCREASE MINORITY REPRESENTATION IN THE COMMUNITY SITES AND YOUR PACKETS WILL CERTAINLY WAS REPORTED THE OVERALL NIGH NORTY ENROLLMENT IS UP 20%, 15% COMMUNITY SITES AN 52% IN MINORITY UNDERSERVED SITES. AS WE MOVE FORWARD BECAUSE WE HAVE INITIATIVES LOOKING AT OTHER UNDER-REPRESENTED POPULATIONS SUCH AS ADOLESCENCE AND YOUNG ADULTS SPECIFIC APPRECIATION OF THE LOW AMOUNT OF ENROLLMENT OF ELDERLY, WE CAN PROVIDE TAT DATA AND CONTRIBUTIONS FROM BOTH COMMUNITY SITES IN THEIR AREA AS WELL AS PARTNERING WITH CENTER TO REDUCE CANCER HEALTH DISPARITIES AND OUTREACH INITIATIVES. LASTLY, TO PROVIDE SUPPORT IN THE TRANSITION FROM LARGE ADJUVANT TRIALS TO THE MOLECULAR TARGET AND PRECISION TRIALS. AS YOU WILL SEE AS I MOVE FORWARD THE SIGNIFICANT CONTRIBUTION TO THIS AREA, WE HAVE BEEN OBSERVANT AND TAKING SURVEY AND MADE NOTE OF BEST PRACTICES IN OUR COMMUNITIES AS THEY EVOLVE INTO PRECISION MEDICINE FOR TREATMENT AS WELL AS OUR EVOLUTION INTO ATTEMPTING TO MOVE IN THAT DIRECTION AS WELL. BUT IMPORTANTLY WANT TO MAKE SURE AS WE MOVE FORWARD WE'RE ABLE TO SUSTAIN THOSE BEST PRACTICES. THE THIRD QUESTION WAS RELATED TO EFFICIENCY OF STUDY DEVELOPMENT AND ACCRUAL. THE EVALUATION COMMITTEE IDENTIFIED NUMBER OF CONCEPTS AND STRENGTHS IN THAT AREA, 51 CONCEPTS THAT WERE SUBMITTED AND THE 55% APPROVAL RATE FOR THOSE THAT WENT TO STEERING COMMITTEE, THAT WAS EXISTING AT THE TIME. 31 STUDIES ACTIVATED SINCE AUGUST OF 2014 AND AT THAT TIME 23 WERE PENDING ACTIVATION. ACCRUAL FROM 6300 TO 8700 BETWEEN THAT TIME WAS IMPORTANT. NOTED CONTRIBUTION FROM NCTN. N CORPS ENROLLED 44% OF MATCH PATIENTS REGISTERED IN SCREENING. THIS IS A SNAP SHOT OF SEVERAL TRIALS ACTIVATED IN -- SINCE 2014 AT LAUNCH OF N CORP AND COMPLETED THEIR ENROLLMENT. IT FOCUSES ON TRIALS THAT LOOK AT MALIGNANCY SUCH AS DCIS, POPULATIONS SUCH AS ELDERLY, AND SOME TRIALS LOOK COMMON THINGS CONFRONTS ON A DAILY BASIS SUCH AS LEUKOSIGH AT THIS. LEUKOSITIS. IN TERMS OF RESPONSE TO SOME OF THE COMMENTS FROM EFFICACY, THERE WAS A COMMENT TO EXPEDITE TIME LINE OF TRIALS AND COLLABORATE ON MONITORING TIME LINES FOR DEVELOPMENT ACTIVATION OF TRIALS AND TRACKING ON ACCRUAL RATES. WE FORMED A, WHOING GROUP, ONE HAVING TO DO WITH THE FACT AFTER CONSOLIDATION OF THE GROUP AND FIVE NCTN ALSO SERVE TO BE RESEARCH BASIS FOR N CORP, IN OF THEM RECRUITED NEW MEMBERS TO SERVE ON THEIR COMMITTEES SO WE WANTED TO GIVE THEM TIME TO GET THEIR PROCESSES AND TIME LINES TOGETHER, WE WANTED TO ALSO FORM THIS WORKING GROUP TO ASSESS TIME LINES FOR THE STUDIES AND STOPPING GUIDELINES IN THE CONTEXT OF HAVING A NEWLY FORMED CENTRAL I, ARE, BE, HAVING A NEWLY FORMED STEERING COMMITTEE FOR CANCER CARE DELIVERY RESEARCH AS WELL AS NEWLY FORMED COMMITTEE FOR CANCER PREVENTION. THAT IS SOMETHING THAT WILL BE VERY IMPORTANT FOR US TO ADDRESS OUR VERY HETEROGENEOUS RESEARCH PORTFOLIO. THE NCI HAS A -- N CORP HAS A SCREENING LOG TO CAPTURE INDIVIDUALS SCREENED PER TRIAL. WE DEVELOPED THIS LOG THAT IS BEING IMPLEMENTED IN CANCER CONTROL PREVENTION AND MORE RECENTLY IN TREATMENT. WE WANTED TO EXPAND THE AMOUNT OF DEMOGRAPHICS INCLUDED IN CLINICAL TRIALS. WE ALSO COLLECT METHOD OF DIAGNOSIS. WE COLLECTED INFORMATION RELATED TO THE TIME OF INSURANCE AT TIME OF TIGHT NOSEYS WHICH IS IMPORTANT -- DIAGNOSIS BECAUSE PATIENTS NOT INSURED MAY COME THE A SPECIFIC INSTITUTION AND HAVE INSURANCE AT THE TIME SO THAT WAS VERY IMPORTANT. AND IMPORTANT WE'RE ALSO CHECKING COMORBIDITIES TO ADDRESS THE VERY IMPORTANT ISSUE OF ELIGIBILITY. PROGRAM PROPOSES INCREASED FUNDING FOR SCREENING ENROLLMENT OF PATIENTS. OUR TRIALS IN THE CONTEXT OF CANCER CONTROL PREVENTION ARE BECOMING MORE COMPLEX AS WELL AND WE HAVE INFORMATION AS TO THE EFFORT THAT OUR INVESTIGATORS ARE USING TO GET PATIENTS ON TO CLINICAL TRIALS. THE FOURTH ISSUE RELATED TO COLLABORATION. EVALUATION COMMITTEE IDENTIFIED SEVERAL INDICATORS OF COLLABORTION INCLUDING ACROSS RESEARCH BASIS TRIALS AS WELL AS EXTERNAL COLLABORATIONS. THEY NOTED EVIDENCE OF ACTIVE COMMUNITY SITES PARTICIPATION IN RESEARCH BASE COMMITTEES WOULD HAVE SIGNIFICANT REPRESENTATION ALL STEERING COMMITTEES WE HAVE WORKING GROUPS WHICH THERE ARE FIVE TO WHICH WE HAVE SIGNIFICANT PARTICIPATION AS WELL AS OTHER NCI INITIATIVES INCLUDING THE ADVISORY BOARDS. OUR RESPONSE TO SOME OF THE RECOMMENDATIONS INCLUDED THE FACT THAT N CORP PLANS TO CONTINUE TO PROMOTE TRANSRESEARCH AND WE HAVE AN ACTIVE COMMUNITY ADOLESCENTS ADULTS AND ELDERLY, WITH ADOLESCENTS WE HAVE SITES WITH CHILDREN AND ADULTS AND WORKING HARD TO MAKE SURE PROTOCOLS APPROPRIATE FOR THAT AGE ARE ACTIVE LE ENROLLED. THE N CORP WORKING GROUPS DESIGN TO WORK TOGETHER WITH EXPERTS TO SERVE AS CHAMPIONS FOR TRIALS PARTICULARLY AS WE MOVE TO PREVENTION SURVEILLANCE TRIALS. WITH RESPECT TO PROFESSIONAL SOCIETIES, AND PROSPECT TVLY ADDRESS BARRIERS TO ENROLLMENT BY THE EXPERTISE THAT IMPORTANTLY MAYBE NON-ON COLOGICAL EXPERTISE. WE HAVE SEVERAL ONGOING COLLABORATIONS WITH ORGANIZATIONS SUCH AS PCORE IN OUR CANCER CONTROL AS WELL AS CANCER CARE DELIVERY RESEARCH PORTFOLIO. PARTNERSHIPS COLLABORATION WITH ASCO SOME WHICH YOU HEARD ABOUT TODAY, ACR INTERNATIONAL GROUPS AND OTHER NIH INSTITUTES. THE FIFTH AND LAST QUESTION, ON CANCER CARE DELIVERY. THE EVALUATION COMMITTEE NOTED THE N CORP OFFERS CLEAR ADVANTAGES FOR CONDUCT OF KAREN CARE DELIVERY STUDIES AN SERVES AS A MICROCOSM OF THE LARGER DELIVERY HEALTHCARE ENVIRONMENT. N CORP SHOULD EXPAND PARTICIPATION OF COMMUNITY ONOLOGISTS AND CHIEF OPERATING OFFICER IN STUDY DESIGN WITH RECOMMENDATION TO CANCER CARE DELIVERY RESEARCH. THEY HAVE BEEN ASSESSMENTS OF CAPACITY, VIA THE LANDSCAPE ASSESSMENT, THE SITES HAVE NOW ENGAGED STAKEHOLDERS SUCH AS THE CHIEF OPERATING OFFICER AND CHIEF CEOs IN CCR BECAUSE WE UNDERSTAND THAT MANY OF THE HOSPITAL ACQUISITIONS HAVE NEW LEADERSHIP AND IT'S IMPORTANT TO ENGAGE SO THEY'RE SUPPORTIVE OF RESEARCH. THE N CORP SHOULD EXPLORE OPPORTUNITIES IN CARE AND BIG DATA. I WANTED TO SHOW THIS SLIDE TO REALLY SHOW IF YOU LOOK ON THE LEFT, BIG DATA ACTIVITIES ARE EXISTING, HOW THIS IS -- HYPOTHESIS GENERATING, N CORE SITES ARE LESS FAMILIAR WITH OR HAVE CAPACITY FOR CROSS TALK SO BASICALLY WHERE WE FOCUS WHERE WE HAVE GAPS IN THE PORTFOLIO, WE ARE ABLE TO DO -- MULTI-CENTER PARTICIPATION FOR THE CANCER CARE DELIVERY RESEARCH N CORP LABORATORY FOR THATND OTHER FACTORS LISTED THERE SO THE POINT WAS THAT BIG DATA IS REALLY DEEMED APPROPRIATE FOR THE N CORP SITE AT THIS TIME. JUST WANT TO SHARE WITH YOU THE EXPERTISE IN CANCER CARE DELIVERY RESEARCH, THE LEADING THOUGHT LEADERS IN THIS AREA, POPULATED ON OUR STEERING COMMITTEES AND OTHER REVIEW EFFORTS AND COMMITTEES WITHIN OUR RESEARCH BASIS. SO THE OVERALL RECOMMENDATION WAS THAT NCI SHOULD PROCEED WITH THE N CORP RFA REISSUANCE. SO AS WE DID, AT THE BEGINNING OF N CORP SHOULD WE MOVE FORWARD WE ARE PRESENTED TO YOU TODAY SCHEDULED TO THE BOARD OF SCIENTIFIC ADVISERS AT THE END OF THE MONTH. CONVENE MAJOR STAKEHOLDERS TO HELP AS WE MOVE FORWARD WITH PLANNING SUCH A REISSUANCE AND I LISTED THEM HERE. SO WHERE DO YOU WANT TO GO IN THE FUTURE? WE LAUNCHED THE TRIAL AS AN EXAMPLE BUT HOPE TO HAVE A ROBUST REPOSITORY UPDATED THAT WILL HELP MOVE FORWARD OUR ENTIRE PORTFOLIO. IN AREA OF SURVEILLANCE WHICH IS INCREASINGLY IMPORTANT DISCUSSION, WE OTHER LOOKING AT TIMING TO SURVEILLANCE COLON CANCER, LOOKING AT PANCREATIC CYST PROGRESSION, IN THE AREA OF CANCER PREVENTION. WE LIKE TO LOOK AT DIFFERENT MECHANISMS OF ADMINISTRATING AGENTS SUCH AS TOPICAL. HPV DOSE SCHEDULING AND UTILIZATION PEDIATRIC CANCER SURVIVORS AND UTILIZING THE PRE-CANCER ADD LIST TO HELP MOVE FORWARD IN PREMALIGNANT RESEARCH. IN THE AREA OF SYMPTOM SCIENCE WE LIKE TO ASSESS IMMUNOTHERAPY RELATED TOXICITIES AND OTHER TARGET AGENTS COMING ON BOARD. AND ALSO LIKE TO EXPAND N CORP TO INCLUDE AREAS WE KNOW THAT ARE UNDER-REPRESENTED. I WOULD LIKE TO HIGHLIGHT PERHAPS THE NORTHERN NEW ENGLAND AREAS WE HAVE NOT HAD REPRESENTATION IN THE NETWORK. AND SOME OF -- FEW OF THE SOUTHERN STATES. THERE ARE TWO SCIENTIFIC AREAS WE WOULD LIKE TO MOVE FORWARD. ONE HAVING TO DO WITH IMPLEMENTATION, ONE EXAMPLE I WILL HIGHLIGHT, SECOND ONE IS WE HAVE CERTAINLY SIGNIFICANT RURAL AREAS AND FOUND IN OUR ASSESSMENT LESS THAN ONE-THIRD OF THE SITES HAVE PRACTICES REPORTING UTILIZATION OF O TELEHEALTH. THE SECOND AREA SEASON IMPORTANT ONE IMPLEMENTATION. AN EXAMPLE HERE WOULD BE THE FACT CONTRALATERAL PROPHYLACTIC MASTECTOMY, NO SURVIVAL BENEFIT YET SIGNIFICANTLY CONTINUING TO BE USED IN THE COMMUNITY. WE ARE VERY INTERESTED IN FINANCIAL TOXICITY AND HAVE STUDIES THAT ARE ONGOING IN THAT PARTICULAR AREA. WE KNOW THAT BANKRUPTCIES ASSOCIATED WITH 50% DECREASE IN SURVIVAL SO THESE ARE SOME OF THE AREAS WE WOULD LIKE TO TAKE N CORP AS WE MOVE FORWARD. THAT IS MY PRESENTATION. I'M HAPPY TO TAKE QUESTION. >> WONDERFUL PRESENTATION. PROGRAM HAS MADE A LOT OF PROGRESS OVER LAST COUPLE OF YEARS, GREAT TO SEE. A LOT ARE INVOLVED IN THIS ACTIVITY. I KNOW PAT PARTICIPATED IN THE -- ARE YOU VIA PHONE? >> YES, I'M ON. >> HI N IKIL. I WANT TO EMPHASIZE WHAT A WONDERFUL JOB YOU DID WHERTA IN PUTTING TOGETHER THE REPORT AND THE PROGRESS MADE. I CANDIDLY HAVE BEEN MORE NCTN SIDE OF THINGS AND WAS A LITTLE BIT AGNOSTIC ABOUT THE WORK BEING DONE BUT YOU HAVE DONE EXTRAORDINARY WORK, A LOT OF WORK. SEVERAL YEARS AGO THEY HAD THE CTOPS AND NCCT PROGRAM AND FOR MANY PEOPLE AT THE ACADEMIC INSTITUTIONS WE WERE A LITTLE NOT SURE THE RIGHT WORD. THERE WAS AN EMOTION THAT WE HAD WITH MANY OF THESE SITES THAT WERE PICKED OF, MAYBE IN THE SAME NEIGHBORHOOD AS CANCER CENTER, BUT YET THEY PICK A RESEARCH SO IT THAT WOULD BE SOMEWHERE FAR AWAY. THE NOTION WAS THEY REALLY -- THEY WERE COMPETING TO SAY JOSIASER AS GOD AS CANCER CENTERS, IT WAS TRYING TO GET PATIENTS THERE. IT WAS USED AS A MARKETING TOOL. I THINK SOME OF THE DATA THAT YOU HAVE HERE, I THINK IS VERY INTERESTING PARTICULARLY SINCE, I DON'T KNOW, ABOUT HALF OF THE PATIENTS GOING ON CANCER CONTROL STUDIES ARE COMING FROM THIS GROUP. WHEN YOU LOOK AT THERAPEUTIC TRIALS ONLY 35% OF ACCRUALS THERE SO THERE'S A DIFFERENT DIFFERENCE BETWEEN IN THE COMMUNITY SCIENCE, A DIFFERENT KIND OF PATIENT PROFILE THAT ARE GOING ON THESE TRIALS AND THERE ARE, THE SITES MORE THERAPEUTIC THIS IS MORE CANCER CONTROL. THIS IS AN IMPORTANT DISTINCTION AND IT BODES TO HAVE PARTNERSHIPS NOW WHERE WE DON'T FEEL WE'RE COMPETING WITH EACH OTHER BUT SYNERGISTIC. TO THAT POINT WAFF A WONDERFUL MAP WITH ALL THESE SITES. I WOULD LOVE TO SEE ANOTHER MAP WITH THE NATIONAL CANCER CENTERS SITES TO SUPERIMPOSE TO SHOW THIS MESSAGE THAT WE ARE NOW INCORPORATING THE ENTIRE COUNTRY AND I THINK THESE ARE VERY SYNERGISTIC IN TERMS OF THE COVERAGE OF WHAT WE'RE DOING. THE OTHER ASPECT IN YOUR REPORT YOU TALKED I THINK THERE'S A LITTLE BIT OF LANGUAGE, YOU BROUGHT UP ABOUT THE DIFFERENCES IN MINORITY ACCRUAL. MANY URBAN SITES ARE FAMILIAR WITH ACCRUAL, THE MU SITES IF YOU WILL. BUT THEN IN MANY OTHER ONES, THE ACCRUAL IS MUCH LOWER WHICH MIRRORS WHAT YOU'RE SEEING IN NEBRASKA T. POPULATION OF THE UNDERSERVED WITH THE EXCEPTION OF NATIVE AMERICANS. I THINK WHAT YOU HAVE DONE IS PUT TOGETHER A PROGRAM THAT ALLOWS US TO GET A REALLY THE FLAVOR OF THE ENTIRE POPULATION IN THE UNITED STATES. APPLAUD YOUR WORK. >> THANKS, NIKIL. >> HI, SO I WOULD LIKE TO ECHO PAT'S COMMENTS TO SOME EXTENT. AND ROBIN AND WHERTA DID A SUPER JOB IN A SHORT PERIOD TO HELP US REVIEW THIS INFORMATION. WHAT N CORP BRINGS THAT WAS SO SURPRISING AND IMPORTANT IS BRING THE REAL LIFE SCENARIO AND REAL LIFE PATIENTS THERE. 90% OF PATIENTS ARE SEEN IN IMMUNITY, ACADEMIC INSTITUTION, MORE SELECT PATIENTS AND THIS N CORP SITES BRINGS REAL PATIENTS TO OUR STUDIES, MAKING IT MORE MEANINGFUL. THAT ASPECT WE CANNOT UNDERESTIMATE ITS IMPORTANCE IN WHAT COMES OUT OF THIS STUDY. THE SECOND POINT WAS THERE'S REALLY NO OVERLAP IN THE CCOG PROVIDES PATIENTS TO NCTN AND DOES SECONDARY WORK. IT WAS CLEAR THAT NCORP HAS ITS OWN CLEAR ROLE NOT OVERLAPPING WITH NCTN, IT DOES A LESS -- TREATMENT JOURNALS AND STUDIES WHILE N CORP FOCUSES ON MORE DAY TO DAY PROBLEMS CANCER PREVENTION CONTROL CARE DELIVERY COMPARATIVE EFFECTIVENESS AND OVERLAPPING IN THEIR -- SO N CORP NEEDED CLEARLY DEMONSTRATED THERE. AND THEIR COMPLIMENT, THERE'S CERTAIN QUESTIONS WE DISCUSSED IN THIS COMMITTEE ABOUT ACCRUAL PROBLEMS AND NCTN WAS MORE SIGNIFICANT ACCRUAL PROBLEM THAT'S A REALLY IMPORTANT CONTRIBUTION AND NEED FOR THIS PROGRAM. THEN FINALLY I THINK IT BRINGS LARGE NUMBER OF COMMUNITY ONCOLOGISTS INTO THIS RESEARCH FOLD, THEY WOULD BE THINKING FROM THE ANGLE OF HOW TO DO RESEARCH AND HOW TO GET DATA AND HOW TO EVALUATE IT. THAT UTILIZE THAT KNOWLEDGE FOR OTHER PART OF THE PRACTICE. AND OTHER PART OF PATIENT CARE ALSO. ALMOST 4,000 ONCOLOGISTS AS MEMBERS AND I THINK THAT'S AN IMPORTANT COMPLIMENT THAT N CORP BRINGS WHICH IS HIGHLIGHTED DURING THE REVIEW. SUGGESTING THE NEED FOR THIS PROGRAM. IF YOU LOOK AT THE CENTER WHERE THIS PROGRAM IS ACTIVE SOME OF THE CENTERS ARE IN SPARSELY POPULATED AREAS IN THE NORTH AND NORTHWEST, LESS POPULATION, PROVIDE THIS ACCESS TO NEW DRUGS AND TREATMENT. I THINK THERE ARE MANY, MANY PLUSES THAT CAME OUT OF REVIEW THAT MAKES N CORP INDISPENSABLE AND COMPLIMENTARY PARTNER TO NCTN PROGRAM. SPECIFICS SO CLEARLY DEMONSTRATE AND DESCRIBE SOME OF THE CHANGES SOME OF THE FOCUS SHIFTED FROM OLDER STUDIES TO NEWER GENOMICS AND OTHER STUDIES THAT WE CAN HAVE IN N CORP AND FOCUS IN THAT AREA. I THINK IT WAS VERY WELL DONE REVIEW, CLEARLY DEMONSTRATED NEED TO HAVE THESE EFFORTS CONTINUE AND FUNDED EVEN MORE. >> THIS IS OUR CHANCE TO COMMENT BEFORE IT GOES TO BSA LATER THIS MONTH. AUGUSTA. >> I WOULD LIKE TO ADD TO WHAT NIKIL JUST SAID. I THINK AS A PI IN ONE OF THE MINORITY UNDERSERVED N CORP, THINK ONE OF THE THINGS THAT HAS REALLY CHANGED IS THAT IT'S GARNERED A TREMENDOUS AMOUNT OF RESPECTED FROM COMMUNITY ONCOLOGIST, BEFORE LUKE WARM WITH CCOPS AND DECIDED TO PARTICIPATE ON THEIR OWN OR NOT EVEN PARTICIPATE BUT THE N CORP BROUGHT RENEWED INTEREST BECAUSE IT BRINGS THE NEW GENOMIC BASED TRIALS, NEW PARTICIPATION IN STUDIES THAT ARE CANCER CARE DELIVERY RESEARCH AND CANCER CONTROL THAT BEFORE USED TO BE SET ASIDE BY COMMUNITY ONCOLOGISTS. I THINK THE FACT THAT THEY ARE NOW GETTING EDUCATED AND WHAT IS GENOMIC MEDICINE, IF YOU THINK OF THE COMMUNITY ONCOLOGISTS WHO WAS TRAINED 10, 15 YEARS AGO, THERE WAS NO GENOMIC MEDICINE AT THAT TIME. THIS IS THE OPPORTUNITY TO PARTICIPATE, BECOME EDUCATED ACCESS TO CLINICAL TRIALS AND INSTEAD OF HAVING TO DO THEM, THESE TRIALS ON THEIR OWN, THEY NOW PARTICIPATE IN A NETWORK OF GROUPS THAT HOMOBRING THESE TRIALS AND EDUCATE -- HELP EDUCATE AND THEY HIMSELFS ARE PROPOSING INNOVATIVE APPROACHES; THEY WANT TO PARTICIPATE IN TELEHEALTH,THEY WANT TO PARTICIPATE IN CANCER CONTROL STUDY, SYMPTOM MANAGEMENT AND THINGS OF THAT SORT THAT THEY SEE EVERY SINGLE DAY AND BEFORE DID NOT HAVE ACCESS TO ORGANIZED TRIALS. SO THIS IS AN ABSOLUTE NECESSITY TO CONTINUE. THE PARTICIPATION IN THIS IN CLINICAL TRIALS. >> GREAT REPORT. ONE SUGGESTION TO CONSIDER IS TO LOOK AT THE PUBLICATIONS THAT HAVE COME OUT ALREADY, SOME OF THEM MIGHT BE FROM CCOP LEGACY WORK. AND ALSO THINK ABOUT HOW THE ACTIVITIES OR TRIALS DONE OR ABOUT TO BE DONE ARE CHANGING PRACTICE. IT WOULD BE NICE FOR EVERYONE ADVOCATING FOR N CORP GIVE AN ELEVATOR SPEECH ON THIS PAPER THIS TRIAL THIS CHANGE IN PRACTICE. I'M NOT SURE I SEE THAT IN THE REPORT. AND CLEARLY IN THE NEW NCTN RENEWAL, THAT'S FRONT AND CENTER OF WHETHER WE NEED TO SAY FOR EACH GROUP. I THINK IT WOULD BE GREAT FOR THE PROGRAM. THE SECOND COMMENT IS MORE HERETICAL. THAT IS IT COULD BE FROM MY TWIST PERSPECTIVE, NICE TO THINK OF HOW TO THINK OF THE N CORE MINORITY N CORE UNITS, THE NON-MINORITY N CORE UNITS LABS, NCTN MEMBERS, HOW TO THINK ABOUT IT AS SORT OF A MORE DISTRIBUTED SOLO SYSTEM. RATHER THAN SYSTEM A AND SYSTEM B WHICH IS BECOMING INCREASINGLY ARTIFICIAL IN MY VIEW. MAYBE THAT WAY BECAUSE OF STRUCTURAL ENTITIES WITHIN NCI BUT I DON'T WANT THE N CORP MEMBERS COMING TO THE GROUP SEMIANNUAL MEETINGS ONLY THINKING ABOUT N CORP. I DON'T WANT THE LABS ONLY THINKING ABOUT THE CTEP TRIALS. I WANT THEM ENGAGED AND ON A DOCTOR BY DOCTOR BASIS THEY ARE. SO FIGURING HOW TO BREAK THOSE BARRIERS DOWN WHILE WE HAVE EXISTING CONSTRUCTS IN NCI, I THINK WOULD BE GOOD. >> I SPENT THE FIRST NINE YEARS OF MY CAREER IN COMMUNITY CANCER CENTER AND 15 YEARS AT CCOP RESEARCH BASE WHERE I INTERACTED VERY STRONGLY WITH COMMUNITY CCOPS. I DO THINK IT WOULD BE NICE TO FIGURE OUT A WAY TO PRODUCE DATA TO SHOW TRANSLATION TO PRACTICE MY EXPERIENCE HAS BEEN PARTICIPATING IN THOSE CLINICAL TRIALS LEADS PEOPLE TO BE EARLY ADOPTERS WHEN THE RESULTS COME OUT AND IT WOULD BE NICE TO BE ABLE TO HAVE ACTUAL DATA TO SHOW THAT. IN TERMS OF YOUR COMMENT ON CHANGING PRACTICE I HAVE BEEN INVOLVED IN A LOT OF GUIDELINE WORK THAT DOES SITE N CORP TRIALS AS EVIDENCE BASE. I I DO THINK THAT SO THAT DEFINITELY IS OUT THERE AND PROBABLY WOULD BE LOW HANGING FRUIT TO TOM A REPORT ON THAT. THE OTHER SIDE TO SHOW WE KNOW THERE'S ISSUE WITH TRANSLATING CLINICAL PRACTICE GUIDELINES INTO PRACTICE WHICH IS ANOTHER AREA RIPE FOR CANCER CARE DELIVERY RESEARCH TO BE ABLE TO IMPROVE BUT I THINK IN THE N CORP SITES THAT DOES HAPPEN MORE QUICKLY AND WOULD BE VERY NICE TO BE ABLE TO DEVELOP DATA TO SHOW THAT. >> I KNOW YOU'RE INVOLVED WITH CANCER CARE DELIVERY GROUP IS THERE ANYTHING YOU WANT TO ADD? >> YEAH. I THINK THE COMMENTS ALREADY >> YOUR MIC IS OFF. >> I THINK THE COMMENTS DELIVERED ALREADY HAVE MENTIONED A LOT OF THE STRENGTHS THAT N CORP BRINGS TO THE NCI CLINICAL RESEARCH PROGRAM. JUST WANT TO CONGRATULATE WHERTA FOR AN EXCELLENT REPORT REVIEW AND THANK HER FOR HER STEWARDSHIP OF THIS COMPLEX DIVERSE RESEARCH CLINICAL RESEARCH RESOURCE. IT'S BEEN CHALLENGING TO HOLD THIS TOGETHER AND PUT TOGETHER THE DIFFERENT ORGANIZATIONS. SO I WANT THE MAKE SURE THAT'S RECOGNIZED AS WELL. >> ONE OF THE RECOMMENDATIONS ON THIS IS TO ENGAGE CEOs AND I ASSUME YOU ARE PRACTICING CEOs -- MY QUESTION IS THERE ANY WAY TO ENGAGE INSURANCE COMPANIES, SOME OF THEM INTO THE PERFORMANCE OF THESE TRIALS AS THEY HAVE (INAUDIBLE). >> DID YOU WANT TO TAKE -- >> I'M KATE CASTRO ONE OF THE CCD OPERATIONS LEADS. THAT'S AN EXCELLENT QUESTION. AS ALLUDED TO IN HER PRESENTATION THE RESEARCH BASIS GROUP TOGETHER DID TWO LANDSCAPE ASSESSMENT AS WE INITIATED THE N CORP TO LOOK WHAT CAPACITY WAS TO DO CANCER CARE DELIVERY RESEARCH WITHIN THE PROGRAM. THE MOST RECENT ONE WAS DONE IN 2017 IN THE SPRING. AND WE HAD OVER 500 COMPONENTS AND PARTICIPANTS THAT PARENT PATED IN THAT. ONE THING WE LEARNED FROM THAT IS THE INSURANCE MARKET IS SO RAPIDLY CHANGING, IN ALL THE STATES, AND THE RESEARCH BASES WERE INTERESTED IN POSSIBILITY OF LOOKING AT DOING SOME RESEARCH IN THIS AREA BUT RIGHT NOW IT LOOKS LIKE THAT IS SOMETHING THAT WE JUST ARE GOING TO HOLD ON IT WILL THEY CAN SEE IF THINGS SETTLE OUT BECAUSE THERE'S A LOT OF CHANGE GOING ON WITH THE CHANGES IN HEALTHCARE. >> DAVID, LAST COMMENT. >> THAT'S DANGEROUS. WHAT I WANTED TO ADD WITH RESPECT TO RESEARCH BASE WITH KNEE MORES LAST TIME AND I WANT TO CONGRATULATE YOU BECAUSE YOU ADDRESSED VERY IMPORTANT SCIENTIFIC CONCEPTS. ONE OF THE THINGS I REMEMBER FROM REVIEW IS YOU HAVE SUCH A DIVERSITY OF SCIENTIFIC QUESTIONS, THAT IT'S REALLY HARD FOR ANY INDIVIDUAL RESEARCH BASE TO BE GOOD AT ALL OF THEM, I'M WONDERING TO WHAT EXTENT THE NEW RFA WILL CONTINUE TO ENCOURAGE THE RESEARCH BASIS TO NOT NECESSARILY HAVE TO BE GOD AT EVERY SINGLE COMPONENT AND MAYBE EVEN ENCOURAGE GIVEN DIVERSITY OF YOUR MISSION, SOME SPECIALIZATION WITHIN THE RESEARCH BASES YOU HAVE. >> THANK YOU FOR THAT COMMENT. ACTUALLY IT HAS ALWAYS BEEN IN OUR DISCUSSIONS WITH THE APPLICANTS AND RESEARCH BASIS IN PARTICULAR THAT THEY DON'T HAVE TO CHOOSE ALL OF THEM. IT'S VERY INTERESTING BECAUSE AS YOU HAVE NOTED SCREENING AND SURVEILLANCE SOME RESEARCH BASES THAT HAVE RECRUITED EXPERTISE OR HAD IT IN PLACE AND THOSE ARE COMING TO FRUITION. WE ALSO HAVE TWO ACADEMIC INSTITUTIONS THAT DON'T DO PREVENTION JUST DO CANCER CONTROL SPECIFIC SYMPTOM SCIENCE SO WE CAN REITERATE THAT BUT I THINK WE BROADENED THE SITES ARE FOCUSING AND REINFORCE THEIR PARTICULAR EXPERTISE AND WON'T ADDRESS EVERYTHING. >> I'LL FOLLOW ON HERETICAL GROUP WALLY STARTED, MAYBE ENCOURAGE BECAUSE QUALITY OF SCIENCE OVERALL. >> THANKS VERY MUCH, CONGRATULATIONS AND GOOD LUCK WITH THE BSA. IN NEXT PRESENTATION IS ONE THAT I THINK CAME OUT OF OUR WISHES OF OUR DIALOGUE. WE WILL CONTINUE DISCUSSION ABOUT HAVING BETTER INTERACTIONS BETWEEN NCI AND VA. SO WE WILL HEAR FROM THE GROUP CALLED NAVIGATE. NCI VA ENTERAGENCY GROUP TO ACCELERATE TRIALS ENROLLMENT. THAT'S A PRESENTATION BY SHEILA. BY MIKE KELLEY AND GRANT HUANG. SHEILA WILL KICK IT OFF FOR US. >> THANK YOU. COW HEAR ME FINE IN THE BACK? GREAT. THANKS. THANK YOU FOR THE OPPORTUNITY TO PRESENT THIS PROGRAM. AS DR. DAVIDSON MENTIONED I HAVE TWO VA COLLEAGUES HERE PRESENTING ON BEHALF OF A GROUP. SO MIKE KELLEY ASSOCIATED WITH ME TODAY PARTICIPATING HERE AND WE HAVE GRANT HUANG FROM THE COOPERATIVE STUDIES AT VA BOTH WORKING WITH COLLEAGUES ON THIS PROGRAM. SO WHAT IS THIS INTERAGENCY AGREEMENT WE CALL NAVIGATE? IT'S A COLLABORATION BETWEEN THE NCI AND THE VA TO FACILITATE ENROLLMENT OF VETERANS INTO NCI FUNDED CLINICAL TRIALS. ALSO AN OPPORTUNITY FOR THE GOVERNMENT AGENCIES TO PARTNER WITH NATIONAL LEVEL TO MAKE CLINICAL TRIALS MORE ACCESSIBLE AND ACCELERATE CANCER RESEARCH NEW CANCER THERAPIES AS WELL AS NOVEL APPROACHES TO PREVENTION AND THE EARLY DETECTION OF CANCER. SO BESIDES THE COLLEAGUES HERE WITH ME TODAY THERE ARE OTHER FOLKS THAT WORKED ON PUTTING THIS PROGRAM TOGETHER INCLUDING ANDREA DENICOFF WHO I BELIEVE IS HERE, NCI PAY PETRISIAN WITH NCI AS WELL AS MANY PEOPLE THE COOPERATIVE STUDIES PROGRAM AND THROUGHOUT VA TO PUT THIS TOGETHER. I'LL PROVIDE A LITTLE BIT ABOUT VA BACKGROUND AND SO WE HAVE A SENSE OF PUTTING THIS INTO CONTEXT. THE VA MEDICAL CENTERS ARE PART OF AN EXTENSIVE HEALTHCARE DELIVERY SYSTEM THAT IS SUBSTANTIAL EXPERTISE IN THE TREATMENT OF CANCER. THE COOPERATIVE STUDIES PROGRAM IS THE GROUP GRANT IS OVERSEEING UTILIZED CENTRALIZED APPROACH TO ADDRESS SITE LEVEL CHALLENGES TO MORE EFFICIENTLY RECRUIT PATIENTS TO,NANAL TRIALS. VA MEDICAL CENTERS ARE INVOLVED IN NCI CLINICAL TRIALS BUT REALLY FOR REASONS THAT WE TALK ABOUT A LITTLE BIT, ABOUT A YEAR AGO, SOME OF THAT PARTICIPATION DECLINED IN THE PAST DECADE. INCLUSION OF VA PATIENTS AND NCTN AND N CORP TRIALS WE BELIEVE LIKELY TO ADVANCE HEALTH OF THE VA POPULATION AS WELL AS NCI NETWORK TRIALS AND NCTN AS WELL AS N CORP TRIALS. AT LEADERSHIP LEVEL THERE'S RENEWED INTEREST IN THE PAST YEAR REINVIGORATING RELATIONSHIPS BETWEEN NCI AND VA AND INCLUDING INCREASING V ACTION PARTICIPATION IN NCI CLINICAL TRIALS. SO THIS IS JUST SOME -- A SLIDE FROM ARTICLE THAT MIKE PROVIDED ME THAT DESCRIBES RECENT PUBLICATION IN TO 2017 LOOKING AT CANCER BURDEN IN THE V ACTION POPULATION. SO THIS IS TO GIVE YOU A SENSE OF NUMBERS OF CASES OF CANCER ON ANNUAL BASIS, THESE ARE DATA FROM 2010. ALTHOUGH WHAT YOU CAN EXPECT THERE WERE APPROXIMATELY 50,000 CASES OR SO, OF THAT VAST MAJORITY WERE MEN BECAUSE BY 97% OF THE CASES OCCURRED BASICALLY THE POPULATION THAT IS BEING SEEN THOUGH THERE ARE CASES IN WOMEN AND PROBABLY THAT IS SOMETHING THAT WOULD INCREASE SOMEWHAT OVER TIME. THEN AS YOU MIGHT EXPECT, THESE ARE THE -- YOU SEE THE FREQUENCY OF THE ACTUAL CANCER SITES AND NUMBER OF CASES THAT ARE SEEN IN THE VA POPULATION INYOU HAVE HAD CLOGGING PROSTATE COLON CANCER BEING TOP THREE SITES. THIS SLIDE IS TO ALSO GIVE YOU A FLAVOR OF WHERE THESE CASES ARE IN THE VA SYSTEM. YOU CAN SEE THEY ARE SPREAD NATIONALLY, ANOTHER CANCER CASE OCCURRING ACROSS THE COUNTRY AS WELL AS YOU CAN SEE 20% OF CASES ARE OCCURRING MINORITY POPULATIONS. ADDITIONALLY THE CASES WITHIN VA SYSTEM VICE PRESIDENT SLIGHTLY -- APPROXIMATELY ABOUT THE SAME AGE ADJUSTED RATES SEEN IN THE U.S. POPULATION. MAYBE SLIGHTLY A LITTLE BIT HIGHER IN THIS PARTICULAR YEAR. SO WE LOOKED AT ACCRUALINGS IN VA POPULATIONS TO THE LARGE NETWORK TRIALS OVER THE LAST THREE YEARS AND AGAIN THIS IS ACCRUAL TO THE NCTN TREATMENT TRIALS ONLY AND IS FOR THE FIRST THREE YEARS OF THE GRANT YEAR OF THE NEW NCTN NETWORK. WHAT YOU CAN SEE TO THE FAR RIGHT IS A TOTAL OF 325 CASES ACCRUED TO NCTN TRIALS, OVER THAT TIME PERIOD TREATMENT TRIALS, APPROXIMATELY ONE-THIRD OF THEM WERE FROM MINORITY POPULATIONS. YOU CAN SEE COOL DOWN ACROSS THE DIFFERENCE BETWEEN FIRST SECOND AND THIRD YEAR, NOT SURE THERE'S A DECLINE THERE, NOT SURE WHY BUT THIS IS WHAT THE DATA ARE FOR, ACCRUAL TO NETWORKS TRIALS IN THE PAST THREE YEARS. WE HOPE WE COULD IMPROVE UPON THAT. THE OTHER THING TO NOTE IS THAT THERE ARE 35 SITES CONTRIBUTED TO THIS ACCRUAL. 35 SITES THROUGHOUT THE VA ACCRUAL ON NCTN TRIAL. FOUR OR FIVE OF THOSE SITES CREDIBILITIED OVER 40%. SOME SITES VERY ACTIVE AND SOME THAT ARE STRUGGLING TRYING TO GET PATIENTS ON BUT NOT GETTING AS MANY NCTN TRIALS. ONE THING WE ALSO LOOKED AT, OF THE PATIENTS ON THE TRIALS WHAT WAS THE DISEASE OR LEAD DISEASE FOCUS THAT THE TRIAL PATIENTS WHO WERE GOING ON. AS ONE EXPECT, PROSTATE HEAD AND NECK CANCER WERE THE NUMBER ONE ACCRUING DISEASE SITES. THE OTHER THING IS OF INTEREST TO THIS THOUGH IS YOU WILL SEE IT'S NOT JUST ONE TRIAL, NOT ONE BIG PROSTATE CANCER TRIAL THAT WAS OPEN SO THAT'S WHY ACCRUAL WAS THERE. SO THIS WAS ACROSS SEVEN TRIALS. SO THE NUMBERS IN PARENTHESES ARE NUMBER OF TRIALS OPEN AT THIS ACCRUAL CONTRIBUTED TO. NUMBERS IN LIGHT BLUE SHOW MINORITY EPRESENTATION IN THE ACCRUAL TO THE VARIOUS TRIALS ACROSS DISEASES. SO THAT'S BACKGROUND INFORMATION LETTING YOU KNOW WHAT THE POPULATION CANCER BURDEN IN THE VA SYSTEM IS. I PROBABLY DON'T NEED TELL YOU THIS, YOU ARE DOING CANCER CLINICAL TRIALS BUT THERE ARE SIGNIFICANT BARRIERS THAT ARE -- HAVE BEEN BARRIERS TO VA PARTICIPATION AND NCI NETWORK TRIALS, SOME WERE ACTUAL TRIAL ACTIVATION LEVEL SO REGULATORY POLICY AND COMPLIANCE ISSUES. TECHNOLOGY, DATA SHARING ASSOCIATED INFORMATION SECURITY. TISSUE BANKING. AND OF COURSE OFTEN NOT HAVING LACK OF PERSONNEL AND RESOURCES FOR RECRUITMENT. IN ADDITION I HAVE LISTED BARRIERS THAT MAY ALSO BE AT THE PATIENT LEVEL GIVING TO NCI NETWORK TRIALS. SOME BARRIERS ARE CENTRAL THINGS, POLICY CHANGES COULD HELP WITH AND SOME UNIQUE TO THE INDIVIDUAL SITES THAT ARE ACCRUING PATIENTS TO THE TRIAL. SO WITH THAT BACKGROUND, WHAT IS THE GOAL OF THE PROGRAM THAT WE'RE ABOUT TO LAUNCH? THIS IS THE MAIN GOAL ENABLE MORE VA PATIENTS TO ENROLL NCI NATIONAL CLINICAL TRIALS. THE INITIAL FOCUS WILL BE ON ACTIVITIES TO FACILITATE THE PARTICIPATION OF VA MEDICAL SITES IN NCI TRIALS BUT SOME OF THE LONGER TERM GOAL WILL BE TRY TO SEEK WAYS TO SUSTAIN VA MEDICAL PARTICIPATION BEYOND THE TERM OF THIS INTERAGENCY AGREEMENT. SO THE PRIMARY ACTIVITIES WE SEEK TO SUPPORT BY THIS COLLABORATION PARTNERSHIP WITH THE VA, TO PROVIDE FOR THE NCI TO PROVIDE INFRASTRUCTURE SUPPORT FOR UP TO 8 TO 10 VA SITES FOR ENROLLMENT OF VA PATIENTS TO NCTN AN N CORP CLINICAL TRIALS. WE ALSO PLAN TO FORM EXECUTIVE COMMITTEE WITH FOLKS ON THIS SLIDE PREVIOUSLY BUT INCLUDING THE SAYA INVESTIGATORS INVOLVED IN TRIALS AS WELL AS COOPERATIVE GROUPS. EXECUTIVE COMMITTEE WILL CONCLUDE NCI AND PERSONNEL MEMBERS TO OVERSEE THE ACTIVITIES OF THIS PROGRAM SO SOME OF THE RESPONSIBILITIES FOR THIS GROUP WILL BE TO PROVIDE COORDINATED DIRECTION FOR COLLABORATION, HELP SET TIME LINES AND MILESTONES, MONITOR THE PROGRESS, BE U ONE WILL BE HELPING WITH PROVIDING GUIDANCE IN THE SYSTEM WITH HOW TO COME -- OVERCOME THE SYSTEM WIDE SITE LEVEL BARRIERS SUCH AS CENTRAL IRB UTILIZATION, DATA COLLECTION, INFORMATION SECURITY AND SOME OF THE OTHER BARRIERS THAT I HAD MENTIONED PREVIOUSLY. THIS GROUP WILL LEVERAGE NATIONAL CLINICAL TRIALS CAPABILITIES WITHIN THE VA TO CONDUCT CANCER CLINICAL TRIALS. AND TO IDENTIFY SOME MODELS FOR LONG TERM SUSTAINABILITY AFTER THIS INFRASTRUCTURE SUPPORT FUNDING HAS EXPIRED. SO THE INITIAL TIME LINES FOR THE ACTIVITIES, THE INTERAGENCY AGREEMENT THE PIECE FROM ONE PART OF THE GOVERNMENT TO THE OTHER PART OF THE GOVERNMENT IS COMPLETED OVER THE PAST FEW MONTHS WE HAVE BEEN WORKING WITH THE VA WHO WILL BE RELEASING A SOLICITATION FOR THE FUNDING ANNOUNCEMENT FOR THESE 8 TO 10 SITES THEY ANTICIPATE SUPPORTING. AND WE'RE IN THE PROCESS SIMULTANEOUSLY FORMING THE EXECUTIVE COMMITTEE AND ONCE WE EXPECT THE SITES IDENTIFY SOMETIMES IN THE EARLY WINTER. SO THAT WE HAVE A MEETING TO FORMALLY LAUNCH THE PROGRAM. ONE THINGS THAT POINT OUT COSTS NOT SUPPORTED BY THE INTERAGENCY AGREEMENT, NCI WILL USE ESTABLISHED MECHANISMS FOR THE RESEARCH COSTS ASSOCIATE WITH THE THE TRIAL AND THAT THE VA WILL CONTINUE TO PROVIDE STANDARD NON-RESEARCH MEDICAL CARE FOR THE PATIENTS THAT ARE ACTUALLY ON THE TRIAL. SO THE FUNDING IS FOR INFRASTRUCTURE SUPPORT PRIMARILY SUPPORT RESEARCH NURSING STAFF TO HELP GET THE PATIENTS ON TO THE TRIAL. THIS GIVE I DON'T SAY A SENSE OF THINGS WE THOUGHT ABOUT ANTICIPATED BENEFITS OF THIS PROGRAM. WE HOPE IT WILL INCREASE ACCESS FOR VETERANS TO CANCER CLINICAL TRIALS. WE HOPE WHAT THIS MAY HELP ACCELERATING ACCRUAL TO NCI NETWORK TRIALS, OFFERING WAYS FOR MINORITY PATIENTS WITHIN THE VA TO BE ABLE TO PARTICIPATE ON NCI NETWORK TRIAL. AND INCREASEINGLY ACTIVITY OF VA CLINICAL INVESTIGATORS AND RESEARCHERS AS WELL AS DESIGN SOME OF OUR TRIALS, THE SCIENTIFIC STEERING COMMITTEE AND ENHANCING VA OVERALL LEADERSHIP ROLE IN CANCER CARE AND CLINICAL RESEARCH. SO THAT'S ALL I HAVE IS SORT OF AN OVERVIEW ABOUT THIS PROGRAM, LETTING PEOPLE KNOW THAT WE ARE AT THE BEGINNING TO START WITH THAT. I -- I DON'T KNOW IF MIKE WANTS TO -- ANY ADDITIONAL COMMENTS YOU WANT TO MAKE. RELATED TO THIS BASED ON YOUR PRESENTATION. A LOT SEPARATE -- I DON'T WANT THE PUT ON THE SPOT BUT A LOT WAS GENERATED BY THIS COMMITTEE, WE HAD A PRESENTATION ABOUT A YEAR AND A HALF AGO, WE HEARD ABOUT SOME OF THE THINGS SO WE HAVE BEEN WORKING BLIND THE SCENES AND THEN OF COURSE WITH SOME OF THE GOOD LEADERSHIP NCI AND VA THIS IS WHERE WE ARE. >> VERY BRIEF I HAVE TO USE THE MIC BECAUSE NIKHIL IS ON THE PHONE AND HE'S ALSO A VA INVESTIGATOR FROM WAY BACK. SO THE INITIAL DISCUSSIONS CAME OUT OF THE CANCER MOON SHOT WITH JIM AND OTHERS AT THE WHITE HOUSE TALKING ABOUT HOW INTERAGENCY COOPERATION SHOULD INCREASE AND THIS WAS ONE OF THE THINGS THAT CAME OUT OF IT. SO LAST YEAR I PRESENTED STATE OF CLINICAL TRIALS VA AND YOUR RECOMMENDATIONS HELPED LEAD TO THIS PROPOSAL SO I'M APPRECIATIVE TO SHEILA AND GRANT FOR TAKING THE INITIATIVE TO PUT THIS RFP TOGETHER AND VERY MUCH LOOKING FORWARD TO GETTING THIS OFF THE GROUND AND START THE HARD WORK. >> FIRST I WANT TO THANK SHEILA AND MIKE AND REALLY I THINK IT'S BEEN A FABULOUS EXPERIENCE TO DATE WORKING COLLABORATIVELY. IT'S ONE OF THOSE THINGS HAVING SEEN WHAT WE HAVE DONE TODAY IT'S LIKE GOSH WHEY DIP WE DO IT -- WHY DIDN'T WE DO IT SOONER. BUT IT'S A SITUATION WHERE WE'RE CERTAINLY ON THE VA SIDE AND OFFICE RESEARCH DEVELOPMENT ARE EXCITED ABOUT THIS, NOT ONLY DOES IT HELP WITH VETERANS AND PARTICIPATION OF TRIALS BUT OFFERS A NEW MODEL FOR HOW THAT INTERAGENCY COLLABORATIONS WORK BUT ALSO EFFICIENCIES WITH LEARNING TRIALS. SO WE ACTUALLY HAVE BEEN ABLE TO TALK ABOUT THIS TO SOME OF THE CANCER ADVOCACY GROUPS COME TO MEET WITH VA AND ASK WHAT WE'RE DOING IN CLINICAL TRIALS SO THIS IS SOMETHING WE'RE GOING TO HIGHLIGHT AND WE WANT TO THANK DR. DOROSHOW AND LOWY AND OTHERS WHO HAVE BEEN SUPPORTIVE MAKING THIS HAPPEN. >> I HAVE TO SAY FROM THIS PERSPECTIVE IT'S GREAT BECAUSE I CAN REMEMBER BEING HERE A COUPLE OF YEARS AGO IN THE PERIOD AT THE END GEORGE WEANER SAID WE -- WEINER SAID WE SHOULD TALK ABOUT THE VA. SO IT'S NICE TO SEE HOW IT PROGRESSED. WE APPRECIATE IT. OPEN FOR DISCUSSION. NEAL THEN HOWARD AND THEN NIKHIL I KNOW YOU'RE ON THE PHONE. >> I WOULD LIKE TO COMMENT. >> THIS IS GREAT. IT'S TRAGIC VETERANS DON'T HAVE ACCESS TO THE LATEST TREATMENTS AND MOST COMING THROUGH CLINICAL TRIALS, MOST ARE COMING FROM INDUSTRY, NOT BY WAY OF THE GOVERNMENT. KEISER HAS A VERY INNOVATIVE PROGRAM AT LEAST IN SOUTHERN CALIFORNIA IF A PATIENT IS ELIGIBLE FOR CLINICAL TRIAL THEY'LL COVER THE COST WHILE BEING TAKEN CARE OF AT ANOTHER INSTITUTION BACK TO KEISER AT LATER DATE AND HOPE VA WOULD LOOK AT A SIMILAR MODEL. >> RESPONSE FOR THAT? >> YES. >> VETERANS DO HAVE ACCESS TO THE MOST UP TO DATE TREATMENTS, THERE'S NOTHING STANDARD OUTSIDE THEVA THAT'S NOT ALSO STANDARD FOR VETERANS, IF WE DON'T HAVE IT IN OUR SYSTEM WE DELIVER IT OUTSIDE. TO THE POINT OF CLINICAL TRIALS, IT IS A MODEL THAT SOME VA HOSPITALS HAVE BEEN USING TO ENROLL PATIENTS OUTSIDE OF VA BUT NOT -- WE HAVE BEEN HAVING DISCUSSIONS ON WHETHER WE CAN DO THAT, IF SO HOW. BUT CERTAINLY SOMETHING THAT MIGHT COME BACK TO YOU AT SOME POINT. >> IN ONE OF YOUR SLIDES YOU MENTIONED A BARRIER COMORBIDITIES. BUT I WANTED THE GET YOUR FEELING ABOUT WHETHER YOU SEE COMORBIDITIES WITHIN THIS POPULATION, REALLY MAKES IT DESIRABLE MECHANISM FOR STUDY. SO WHAT I'M THINKING ABOUT IS AWARE WITH COMPANY FOR EXAMPLE WHO DID A MYELOMA TRIAL PHASE 2 THAT WAS INTENDED FOR FRAIL ELDERLY PATIENTS. AND I BELIEVE THEY FELT IT WAS (INDISCERNIBLE) SYSTEM AND THEY ANSWERED QUESTIONS ABOUT 80-YEAR-OLD PLUS PATIENTS AND WHAT THEY EXPERIENCE WOULD GET IN CERTAIN -- I MENTION (INAUDIBLE) IT'S THE PRINCIPLE OF THE FRAIL ELDERLY BEING A TOPIC. THE OTHER TOPIC I WONDER ABOUT IS ADHERENCE. WHEN YOU THINK ABOUT THE MILITARY BACKGROUND PEOPLE COMING IN, THERE'S MODERN MILITARY COMMUNICATIONS THE INSURANCE FIELD IS ONE THAT'S A MAJOR ISSUE FOR US AND INDUSTRY, ESPECIALLY FOR ALL OUTPATIENT DRUGS WHERE PEOPLE DON'T ADHERE, DO ADHERE WE TRY TO UNDERSTAND WHETHER THERE'S CERTAIN DEVICES, APPS, THINGS LIKE THAT RELEVANT AND I'M WONDERING WHETHER YOU THINK THE VA BECAUSE OF THE NATURE OF THE POPULATION WOULD ALSO BE A GOOD CANDIDATE FOR THOSE KINDS OF TRIALS. >> DEFINITELY HAVE PATIENTS WHO HAVE COMORBIDITIES AND GENERAL POPULATION. VETERANS AS A GROUP ARE ALTRUISTIC MY PERSONAL IMPRESSION, SHARED BY MANY PEOPLE WHO PRACTICE IN THE VA BUT THERE ARE OFTENTIMES WILLING TO VOLUNTEER FOR ANY CLINICAL TRIALS THAT YOU OFFER THEM. ASKING FOR THEM. IN TERMS OF MYELOMA STUDY, I THINK NIKHIL MAYBE ABLE TO COMMENT ON, AND THEN BE INVOLVED IN THAT ONE. THE V ACTION DOES HAVE A LOT OF NOVEL APPROACHES TO DELIVERING CARE AT A DISTANCE. NOT SURE THE PATIENT CHARACTERISTICS THEMSELVES WOULD BE COMPLIANT FOR THERAPIES FOR EXAMPLE BUT WE HAVE TELEHEALTH, WE CAN DO TELEHEALTH IN THE PATIENT'S HOME, A TABLET OR SOMETHING LIKE THAT, THEY DON'T HAVE ONE. I DON'T KNOW IF THE GRANT HAS ANY INCITES INTO CLINICAL TRIALS USING THE CAP RECORDING DEVICES. >> SO THIS IS NIKHIL. CAN I -- >> YES. THEN GRANT. >> SO I WOULD ECHO THE POINT AND WHAT I WOULD RAISE THE POINT IS A VERY IMPORTANT EXTENT OF THE VA. I WOULD LONG ASSOCIATION, WONDERFUL ASSOCIATION WITH VA DOING STUDIES AND OTHER THING AND HAVING COMORBIDITIES OR FRAILTY IS THE STRENGTH T. WE HAVE AN AGING POPULATION IN THE COUNTRY. AND STUDIES FOCUSED ON THIS PATIENT POPULATIONS ARE SO IMPORTANT TO PROVIDE APPROPRIATE CARE. SO ALTHOUGH IT'S BARRIER FOR CERTAIN TYPE OF STUDY BUT IN ITSELF IT WOULD BE A STRENGTH THAT WE CAN STUDY. IN MYELOMA THAT'S EXACTLY WHAT WAS DONE, USING ONE REGIMEN, HOW WELL PATIENTS WOULD DO WITH PATIENTS WITH OTHER COMORBIDITIES HEART DISEASE, LUNG DISEASE, SMOKING RELATED PROBLEMS AND OTHER. AND HOW THEY CAN BE MANAGED AS EFFECT ACTIVELY AS PATIENT WHOSE DON'T HAVE COMORBIDITIES SO IT'S ACTUALLY I WOULD TAKE IT AS A STRENGTH AND WE PROVIDE UNIQUE PATIENT POPULATION TO STUDY SOME OF THESE QUESTIONS. THE SECOND STRENGTH IS FOR EXAMPLE EXPOSURE TO -- VIETNAM ERA, IT PROVIDES SCIENTIFIC VALIDITY TO PREVENTION AND OTHER ASPECTS OF INTERVENTION AND THE ETHNIC DIVERSITY IT PROVIDES I THINK IS UNIQUE. DR. KELLEY SAID WE HAVE A WONDERFUL COMPUTER SYSTEM, CONNECTIONINGS -- CONNECTIONS WITH REMOTE TELEMEDICINE APPROACHES. THIS IS A VERY OVERDUE APPROACH THEY I'M SO HAPPY THAT IT HAS MOVED TO THIS STAGE. I THINK THE MOST IMPORTANT PART INVESTIGATORS AT THE VA ARE BEST DOCTORS IN THE SYSTEM AND USED TO DOING THIS RESEARCH SO THIS EFFORT WILL FILL UP THE GAP AND WE THINK MAKE THEM A GREAT PARTNER WITH NCI WITH BOTH NCTN AND N CORP STUDIES. >> THERE'S A COUPLE OF WAYS TO LOOK AS SOME ALLUDED TO, IN MY PERSPECTIVE, DESIGN, THAT'S AN ISSUE YOU WANT TO DESIGN A GOOD TRIAL YOU CAN SAY THAT EXEXCLUSION, I THINK THAT WAS THE GENERAL CONTEXT. HOWEVER THAT SAID, I THINK ONE OF THE THINGS THAT FROM ANOTHER CONTEXT WHERE I WAS PLANNING FOR THAT BRAIN INJURY STUDY WHERE SOMEONE RAISED HOW CAN YOU RUN A TRIAL WITH VA WITHOUT NICO MORBIDITIES. THAT'S THE NATURE OF THE PATIENT POPULATION. SO SOME OF THE LESSONS THAT WE HAVE GOTTEN FROM OTHER AREA CERTAINLY HELP INFORM DESIGN OF NCI TRIALS AND OTHERS SO I THINK THAT IS THE STRENGTH IN THAT CONTEXT. THE OTHER POINT TO BRING UP, I THINK THE ADVANTAGE OF SOME OF THESE CONVERSATIONS IN THIS PARTNERSHIP, THOSE NOT FAMILIAR WITH THE COOP RA TESTIFY STUDIES PROGRAM, IT'S BEEN IN VA DECADES, BACK TO 1940s TO THE EARLY TB TRIALS. U THERE'S MEMORY, DESIGN INSTITUTIONAL PRACTICE, WHAT HAVE YOU THAT CAN LEND THEMSELVES TO HELPING TRIALS WHETHER NCI OR OR GROUPS BE MORE EFFICIENT, THAT'S ONE OF THE AIMES OF THIS PARTICULAR COLLABORATION TO SEE WHAT ARE LESSONS LEARNED IN OTHER CONTEXT, WHETHER MENTAL HEALTH, CARDIOVASCULAR DISEASE AND SEE HOW THEY MIGHT APPLY PARTICULARLY IN THE VA HEALTHCARE SYSTEM IN RUNNING THOSE TRIALS. SO THAT'S ONE OF THE THINGS WE HOPE TO BRING IN LEVERAGE AND I THINK THE CHALLENGE THAT WHERE BARRIERS ARE, A LOT OF TIMES TRIALS AS YOU BOTH KNOW HAPPEN MORE ON SITE LEVEL SO ONE SITE MIGHT LEARN SOMETHING BUT HOW IS IT TRANSLATED TO ANOTHER SITE OR SYSTEM AS WHOLE. THIS NAVIGATE AD MORE CENTRALIZED APPROACH, THIS IS AN ISSUE, IS IT SYSTEMATIC, MORE LOCAL, HOW DO WE DEAL WITH THOSE ISSUES. >> THIS IS AN EXCELLENT REPORT. MY QUESTION MY QUESTION IS REGARDING -- I THINK YOUR MIC MIGHT BE OFF. THERE'S AN AGREEMENT IN CONSENT WITH THE V.A. AND ACADEMIC MEDICAL CENTERS SAYS THE END OF WORLD WAR II AND A REPORT A COUPLE YEARS AGO INDICATED THAT THERE WERE 127V.A. CENTERS THAT WERE -- THAT HAD AGREEMENTS WITH 130 MEDICAL SCHOOLS IN THE COUNTRY. SO MY QUESTION IS HAVE WE LEVERAGED THE ASSOCIATION WITH THE MEDICAL CENTERS THAT ARE ALREADY AFFILIATED WITH NCI DIG DESIGNATE OR WITH MEDICAL SCHOOLS THAT HAVE NCI DESIGNATED MEDICAL CENTERS AND REGARDING THE 10 SITES YOU PLAN TO USE ARE THEY ALREADY AFFILIATED WITH MEDICAL CENTERS AND DO THOSE MEDICAL CENTERS HAVE NCI DESIGNATED CANCER CENTERS WHICH IS AN ADVANTAGE. I DON'T KNOW IF THAT'S INCORPORATED ALREADY BUT IF YOU CAN ANSWER THAT, PLEASE. >> I'LL TAKE THE FIRST STEP AND MAYBE MIKE AND SHEILA -- BUT THAT'S BEEN ON OUR MINDS IN DESIGNING THE RFA. WE KNOW IT'S A STRENGTH. WE'VE BEEN CONSIDERING HOW TO INCORPORATE THEM AND WE HAVEN'T SELECTED THE SITES YET BUT WE ANTICIPATE WHEN APPLICATIONS COME IN THAT'S A F FEATURE WE WOULD HIGHLIGHT. >> THERE'S 127 OR V.A. CENTERS AND HAVE AFILL CRAIGIATIONS OF AFFILIATIONS AND ALL DESIGNED FOR TRAINING SO TWO-THIRDS OF U.S. PHYSICIANS RECEIVE SOME KIND OF TRAINING IN THE V.A. SYSTEM AND THAT'S WHY YOU HAVE SO MANY ACADEMIC AFFILIATIONS. THERE'S ABOUT 45 NCI DESIGNATED CENTERS THAT HAVE AN AFFILIATION WITH A MEDICAL CENTER AND WE ANTICIPATE THOSE WOULD BE THE CENTERS MOST LIKELY TO BE COMPETITIVE FOR COMPETITIVE AND TAT A MECHANISM TO BE USED TO DISTRIBUTE INFORMATION ABOUT IT AS WELL. >> GREAT, THIS IS WONDERFUL WORK. I'M INCREDIBLY SUPPORTIVE OF THIS IDEA. I HAVE TWO QUESTIONS AND THEY'RE RELATED. WHEN YOU LOOK NATIONALLY, HAVE YOU DONE AN ANALYSIS OF THE DRIVERS OF SUCCESS VERSUS NOT SO SUCCESSFUL AMONG THE V.A.s IN ACCRUING PATIENTS, WHAT ARE THE VARIABLES BEING VERY ENCOMPASSING AND THE PATIENT DEMOGRAPHICS, ETCETERA. THE OTHER IS THE SIMILAR REVERSE SIDE OF THE COIN, HAVE YOU LOOKED AT THE VARIABLES THAT LOOKED AT THE DECLINES. BETWEEN THE TWO IS THERE I -- A MODEL AS A HIT LIST. YOU'RE SMILING SO IT SOUNDS LIKE YOU'VE DONE IT. >> I'LL ADDRESS IT BROADLY AND OBVIOUSLY MIKE AND SHEILA HAVE COMMENTS ABOUT THAT. THERE'S SEVERAL THINGS WE'RE DOING IN THE PROGRAM. SOME DATA WERE ACTIVELY COLLECTED AND A LOT OF THIS IS ANECDOTAL AS WELL AND I'VE BEEN WITH THE PROGRAM NOW ABOUT 14 YEARS, I ALWAYS ARGUE THE NUMBER ONE SUCCESS FACTOR ARE THE PEOPLE. A LOT OF TIMES WE HAVE INDIVIDUALS AT SITES WHO HAVE NEVER REALLY DONE TRIALS BEFORE AND GET HIRED TO DO IT. ONE THING THAT WAS MENTIONED IN SHEILA'S SLIDES IS TO LEVERAGE THIS EFFORT WE HAVE DONE WITH NCSP WITH THE NETWORK OF DEDICATED ENROLLMENT SITES. RATHER THAN SPUN STUDIES AS INDIVIDUAL, STAND-ALONE PROJECTS, TO HAVE A NETWORK, IF YOU WILL, LOCALLY AND NATIONALLY. NOT ONLY DO YOU HAVE SAY, FOR EXAMPLE, A COORDINATOR THEY DON'T KNOW WHAT TO DO OTHER THAN WHAT THEY'RE TOLD, THEY ARE NOW PARTNERED WITH OTHER PEOPLE WHO HAVE EXPERIENCE AND WHO HAVE ALSO OVERCOME BARRIERS LOCALLY OR NATIONALLY TO DEAL WITH THOSE THINGS. THAT'S THE NUMBER ONE ISSUE. THE OTHER AS WELL IS AGAIN, IT'S AN EXPERIENTIAL FACTOR AND THEY MAY HAVE BEEN SUCCESSFUL BUT WHEN THEY COME TO THE V.A. THEY DON'T KNOW HOW TO NAVIGATE THE SYSTEM OR WHAT THE POLICIES ARE AND THINGS THEY DON'T UNDERSTAND. THOUGH THEY COULD BE THE MOST EXPERIENCED TRIALIST THEY HAVE TO LEARN HOW THE V.A. WORKS. THAT'S ANOTHER FACTOR WE'RE HOPING TO BRING IN. THERE'S OTHER THINGS I CAN TALK ABOUT FOR A LONG PERIOD OF TIME BUT THIS IS AGAIN SOMETHING WITHIN CSP WE'VE BEEN FOCUSSING ON RECRUITMENT IN PARTICULAR THE PAST SEVEN, EIGHT YEARS. NOW WE'RE HOPING THE TIMING IS RIGHT WE CAN NOW LEVERAGE PART OF THAT AS PART OF THE NAVIGATE PROCESS AND I'M SURE MIKE AND SHEILA HAVE OTHER COMMENTS. >> THOSE ARE INSIGHTFUL QUESTIONS AND THERE'S A LONG LIST OF BARRIERS AND WE WON'T GO THROUGH THEM ALL. AS GRANT SAYS, IT'S THE PEOPLE. IT'S THE PEOPLE IN TERMS OF THEIR DEDICATION AND THAT DEDICATION IS NOT ONLY MATCHED WITH EXPERTISE FROM THEIR CLINICAL TRIAL EXPERIENCE BUT ALSO JUST TO WORK THROUGH THE PROBLEMS THAT ARE EXISTING IN ORDER TO GET REGULATORY APPROVAL AND CONDUCT THE STUDIES. SO WHEN YOU TALK ABOUT THE SUCCESSFUL SITES THERE'S A SMALL NUMBER OF SITES I WOULD SAY ARE SUCCESSFUL, ABOUT FOUR. YOU CAN TALK TO THE INVESTIGATORS AT THOSE SITES AND FIND OUT WHAT IT IS EXACTLY THEY DID TO BE SUCCESSFUL. IT'S ALONG THE LINES OF WHAT YOU HEARD TO IDENTIFY INDIVIDUALS LOCATED AT THE V.A. THEY DON'T COME OVER ONE OR TWO DAYS A WEEK. THEY MAY HAVE OTHER COLLEAGUES THAT COME OVER FOR PARTICULAR TRIALS OR SPECIALIZATIONS BUT THEY'RE THERE AT THE V.A. WORKING WITH INDIVIDUALS AT THAT SITE. THEY HAVE SUPPORT FROM THE FACILITY LEADERSHIP. MAYBE EVEN THE REGIONAL LEADERSHIP TO BE SUCCESSFUL. AND THAT'S WHAT IT TAKES. THEY HAVE SOME FINANCIAL SUPPORT TO HAVE THE STAFF TO GO ON. THAT'S WHAT LED TO THAT. I THINK ONE OF THE THINGS THAT'S DESIGNED TO NAVIGATE IS THIS ADMINISTRATIONAL MEMORY ON A NATIONAL LEVEL -- NATIONAL LEVEL ON A KNOWLEDGE BASE TO WORK THROUGH THE BARRIERS TO STUDIES. BECAUSE WE KNOW AT THE TIME FRAME TO OPENING A STUDY THROUGH THE IRB AND V.A. HOSPITAL IS SIGNIFICANTLY LONGER THAN OTHER STUDIES. THAT'S ONE THE THINGS WE HAVE TO CHANGE. >> MY ONLY COMMENT IS I'M NOT AWARE -- WELL, I'M SORRY. THIS IS AN OPPORTUNITY TO SYSTEMICALLY COLLECT THOSE THINGS AND WE'RE BEGINNING SO SHOULD BE SYSTEMICALLY COLLECTING WHAT WE LEARN FROM THIS. I DO KNOW FROM OUR COOPERATIVE GROUPS, THE SWA GROUP HAS HAD AN ACTIVE GROUP IN SHARING. I'VE BEEN IMPRESSED WITH THE SHARE ACROSS OTHER GROUPS AND THEY WORK CLOSELY TOGETHER. >> IF I CAN ADD TO THIS CONVERSATION, I WAS INVOLVED IN THE V.A./NCI INTERAGENCY AGREEMENT BACK IN 1997. WHAT MADE THAT WORK WELL IS THE LEADERSHIP AT THE TOP OF THE V.A. LEEREALLY WANT THE IT TO WORK AND I WORKED FOR A WHILE AND THEN LEADERSHIP CHANGED. YOU NEED COMMITTED INDIVIDUALS AT ALL THE SITES BUT IF YOU DON'T HAVE THE LEADERSHIP AT THE TOP AND THROUGHOUT THE COUNTRY IT'S NOT GOING TO WORK. I IMPLORE THE V.A. TO STAY COMMITTED TO THIS. BECAUSE WE SOLVE PROBLEMS AT THE NATIONAL LEVEL NOT ONE V.A. AT A TIME. >> AND THE SECRETARY AND NOW UNDER SECRETARY IS SUPPORTIVE. THAT LEADERSHIP IS ALSO VERY IMPORTANT. >> THERE'S A SMALL THING, I WANT TO MAKE SURE WE NEED LOOK AT ALL APPLICATIONS AND THEY NEED TO BE JUDGED BY PEER REVIEW WITH THE BEST APPLICATIONS WHAT EDITH INTENDED. I WANT TO CLARIFY THAT AND WHEN WE TALK ABOUT THIS, WHAT I SAW THE TRIALS AND THE INABILITY OF THE V.A. TO ACCEPT THAT. AND IT IS REALLY REMARKABLE THAT TWO LARGE ORGANIZATIONS OF THE FEDERAL GOVERNMENT WERE ABLE TO WORK SYSTEMICALLY AND THROUGH THE BUREAUCRATIC ISSUES AND COME TO A GOOD RESOLUTION. I REALLY APPRECIATE THE COMMITMENT OF THE V.A. AND I HOPE THIS WILL BE THE HARBINGER OF MORE TO COME. THANK YOU. >> ANY OTHER COMMENTS OR QUESTIONS ON THIS? >> AND THE V.A. WHICH WE WERE AFFILIATED WITH WAS NUMBER ONE IN NCTN ENROLLMENT IN THREE YEARS. WE ALSO REALIZE HOW FRAGILE IT IS BECAUSE DUE TO SOME PERSONAL CHANGES THE BOTTOM VERY WELL OUT OF THAT ENROLLMENT IN 2017. SO HAVING A DURABLE HIGH-LEVEL AGREEMENT BETWEEN THE TWO INSTITUTES TO SUSTAIN WHAT IS IN THE BOX IS CRITICAL. >> WELL, THANK YOU. WE'RE EXCITED TO SEE HOW THIS IS COMI COMI COMI COMING ALONG AND WE LOOK FORWARD TO THE IMPLEMENTATION. TODAY WE HAVE TWO DEPUTY DIRECTORS THAT BOTH DOUG AND JIM GRACED WITH US WITH THEIR PRESENCE AND WILL PROVIDE AN UPDATE FROM THE POINT OF VIEW OF THE NCI. >> THANKS, NANCY. I'M GOING TO GO OVER A FEW RELATIVELY HIGH-LEVEL ASPECTS OF WHAT HAS BEEN GOING ON WITH THE NCI AND IN SOME WAYS, MY MOST IMPORTANT SLIDE IS DR. SHARP IS FINALLY THE NCI DIRECTOR AND I COULDN'T BE HAPPIER. HE WAS TERRIFIC WHEN HE WAS THE UNIVERSITY OF NORTH CAROLINA CANCER CENTER DIRECTOR AND I AM VERY CONFIDENT THAT HE WILL BE A TERRIFIC LEADER FOR THE NCI AND NATIONAL CANCER PROGRAM SO, WELCOME, DOCTOR. I FIRST WANT TO TALK ABOUT THE APPROPRIATION SITUATION. MK HOLLIHAND HAS GIVEN YOU INFORMATION IN THE BOOKLET BUT I WANT TO MAKE SURE EVERYONE UNDERSTANDS THOUGH WE TALKED ABOUT THIS AT THE LAST MEETING, THE CANCER MOONSHOT IS SUPPOSED TO BE AN AUGMENTATION OF THE REGULAR APPROPRIATION. AND IN RESEARCH WHAT YOU'RE DISCUSSING COMES THROUGH THE REGULAR APPROPRIATION NOT THROUGH THE MOONSHOT IN ADDITION, I WORRY, WE HAVE GIVEN UNDUE, HIGH PROFILE TO THE CANCER MOONSHOT INITIATIVES AND INADVERTENTLY LESS ATTENTION TO THE RESEARCH THAT IS CARRIED OUT WITH THE REGULAR APPROPRIATION AND SO I WANT TO HIGHLIGHT THAT. I WAS JUST DOWNTOWN WITH THE ROLLOUT OF THE LANCET ONCOLOGY COMMISSION AND I TRIED TO EMPHASIZE THE LAUNDRY LIST OF CRITICAL RESEARCH THAT IS SUPPO SUPPORTED THROUGH THE REGULAR APPROPRIATION AND THE CANCER MOONSHOT IS ONLY SUPPOSED TO SUPPORT A SUBSET OF OUR RESEARCH. WE HAVE A CONTINUING RESOLUTION THROUGH THE FIRST PART OF DECEMBER AND IT INCLUDES SEPARATE FUNDING FOR THE CANCER MOONSHOT AND AS I MENTIONED LAST TIME, THAT CONTINUES TO BE CRITICALLY IMPORTANT AND I REALLY APPRECIATE THAT BOTH HOUSES OF CONGRESS HAVE RECOGNIZED THAT THE CANCER MOONSHOT IS INTENDED TO BE AN AUGMENTATION TO THE REGULAR APPROPRIATION. WE GOT THE FUNDING FOR FY '17 IN MAY RELATIVELY LATE IN THE PHYSICAL YEAR AND WE ARE HOPING THAT WHEN IT COMES TO -- FISCAL YEAR AND WE ARE HOPING WHEN IT COMES TO THE FY-18 APPROPRIATION SOME DECISIONS WILL BE MADE BY THE END OF THIS CALENDAR YEAR. . THE HOUSE MARK-UP WAS $1.7 BILLION OVER THE LEVEL AND THE NCI PORTION IS $82 MILLION. IN ADDITION THE $300 MILLION FROM THE CANCER MOONSHOT. THE SENATE, NOT TO BE OUTDONE, THEY'RE MARK-UP IS FOR $2 BILLION AND NCI WOULD RECEIVE $168 MILLION OVER THE FY-17. AGAIN, AN ADDITIONAL $300 MILLION FOR THE CANCER MOONSHOT. THIS SHOWS YOU FIRST FOR THE NIH AND ANY NEXT SLIDE IS FOR NCI IN PARTICULAR, ON THE LEFT IS THE FY-17 APPROPRIATION. AND THESE WOULD ON THE RIGHT ARE THE HOUSE MARK-UP AND THE SENATE MARK-UP. AND THE HOUSE AND SENATE ARE PROPOSING THE NIH DOES MORE WITH MORE AND THE PRESIDENT'S PROPOSAL IS DOING MORE WITH LESS. YOU SEE A SIMILAR PROFILE WHEN IT COMES TO THE NCI APPROPRIATION. NEEDLESS TO SEE WE NEED TO SEE HOW THIS COMES OUT. THIS SLIDE, WHICH I ACTUALLY SHOWED LAST TIME WAS TO ENUMERATE SOME OF THE RESEARCH SUPPORTED BY THE REGULAR APPROPRIATION TRAINING AND INVESTIGATOR INITIATED RESEARCH AND MOST CLINICAL TRIALS AND THE PMI, ONCOLOGY OF A PROGRAM INCLUDING THE MATCH TRIAL AND THE GRASS INITIATIVE JUST TO MENTION SOME OF THEM. THE PANEL RECOMMENDATION, HOWEVER, IS CERTAINLY VERY IMPORTANT. AND THE NCI HAS WORKED HARD ALONG WITH ALL OF YOU TO TO GET A LARGE NUMBER OF THE RECOMMENDATIONS UNDERWAY ALREADY IN FY-17. WHAT YOU SEE IS A NUMBER OF MOONSHOT INITIATIVES STARTED IN FY-17. EIGHT OF THE TEN RECOMMENDATIONS ARE NOW UNDERWAY WE'RE DOING MORE WITH FY-18 AND BEYOND AND THERE'S MOONSHOT PLANS THAT WERE APPROVED EARLIER THIS SUMMER AND SOME ARE OUT AND SOME WILL BE COMING OUT. I URGE YOU TO LOOK AT THE NCI WEBSITE UNDER CANCER MOONSHOT WHERE THAT'S A FULL LIST OF THE FOAs AVAILABLE. I'M NOW GOING TO TALK ABOUT A NEW INITIATIVE THAT IS PART OF THE CANCER MOONSHOT -- >> PLEASE, PARDON THE INTERRUPTION. YOUR CONFERENCE CONTAINS LESS THAN THREE PARTICIPANTS AT THIS TIME. IF YOU'D LIKE TO CONTINUE PRESS STAR 1 NOW OR THE CONFERENCE WILL BE TERMINATED. >> I MAY BE ABLE TO FILL A ROOM BUT OBVIOUSLY NOT ONLINE. SO THE CANCER IMMUNE MONITORING AND ANALYSIS CENTER AND DATA COMMONS WE PREVIOUS IATE AS CIMACs HAS BEEN STARTED. IT WAS JUST FUNDED TO PROVIDE A STANDARD FUNDED NETWORK OF LABORATORIES TO IMPROVE OUR UNDERSTANDING OF IMMUNOTHERAPY. AS WE ALL KNOW MANY HAVE BENEFITTED FROM IT BUT MANY DON'T. WE DON'T UNDERSTAND WELL ENOUGH WHY SOME PATIENTS RESPOND AND OTHERS DON'T. A CRITICAL PART IS STANDARDIZATION OF VARIOUS IMMUNOLOGICAL DIFFERENCES AND WE HAVE COMPLETED TRIALS WHICH ARE ESSENTIALLY WHERE THERE IS BIOBANKING OF MATERIALS CRYING OUT TO BE ANALYZED. THAT'S WHAT THE CIMAC IS INTENDED TO DO. IT'S A COOPERATIVE GRANT MECHANISM. IT'S USING THE ASPECTS OF THE FREDERICK NATIONAL LABORATORY FOR RESEARCH BUT THERE'S A NUMBER OF EXTRA NEURAL GROUPS, UCSF, STANFORD, MOUNT SINAI AND DANA FAR BER AND SHOWS YOU DIAGRAMATICLY HOW EARLIER LAST MONTH THERE WAS ANNOUNCED A PUBLIC/PRIVATE PARTNERSHIP TO PROVIDE INCREASED SUPPORT FOR CIMAC NETWORK AND RESEARCH BY 11 DIFFERENT PHARMACEUTICAL COMPANIES. THE GOVERNANCE IS GOING TO BE PUBLIC AND PRIVATE. SIMILAR TO THAT OF THE FNIH BIOMARKERS CONSORTIUM. THIS WAS ANNOUNCED AT AN OCTOBER 12 PRESS CONFERENCE AND REID CORTISH IF THE WHITE HOUSE CAME AND THE ACTING SECRETARY OF HHS CAME LESS THAN 36 HOURS AFTER HE HAD BECOME THE ACTING SECRETARY AND THEY BOTH SAID A LOT OF POSITIVE THINGS. AND IT SHOWS THE LEVEL OF THE WHITE HOUSE AND CONGRESS. BACK IN SEPTEMBER THE EIGHT MEMBERS OF THE BLACK CAUCUS CAME AND THANKS TO REPRESENTATIVE LEE THAT BILL DAHUT AND THE HIS COLLEAGUES WERE PART OF THE SCHEDULE BECAUSE CONGRESSWOMAN LEE HAD SEEN A PRESENTATION BACK IN FEBRUARY BECAUSE SHE'S ON THE APPROPRIATION SUBCOMMITTEE AND SAID WHAT THEY'RE DOING IS SO INTERESTING AND SO IMPORTANT WE NEED TO SEE THAT AND ONE MORE EXAMPLE, THE ROLLOUT WITH THE PRESS CONFERENCE, ONE THING DONE WAS TO HAVE AN ADVOCATE AND A PERSON FROM MONTANA CAME TO THE PRESS CONFERENCE AND SHE'S A WOMAN WHO I DESCRIBED HER BRIEFLY LAST TIME BUT SHE HAD CARS CARCINOMA METASTASIS AND SHE IS DOING WELL AND HER SIXTH CHILD NOW HAS HER DRIVER'S LICENSE AND SHE THOUGHT SHE'D BE DEAD SEVERAL YEAR AGO. IT'S REMARKABLE. YESTERDAY I PARTICIPATED WITH LOU WIENER AND OTHERS AT A CONGRESSIONAL BRIEFING ON CANCER AND I THINK IN SOME WAYS THE HIGHLIGHT WAS JACKIE BEALE A 15-YEAR CANCER SURVIVOR AND HAD TWO EPISODES OF BREAST CANCER, A WOMAN OF COLOR AND HEARING HER STORY I THINK MAKES MANIFEST WHY WE ARE DOING WHAT WE ARE DOING. AND BELIEVE ME I'M NOT TRYING TO DENIGRATE OTHER STORIES. KAREN WAS SUPERB AS THE ORGANIZER AND MASTER OF CEREMONIES FOR THIS. BUT THESE KIND OF OPPORTUNITIES PRESENT THEMSELVES ALL THE TIME. I'M SO PLEASED WE CAN HAVE OUR PATIENT SURVIVORS ADVOCATE. I ALSO WANT TO COME BACK TO THE NOTION THAT WE CAN'T DO THIS ALONE AND THE PUBLIC PRIVATE PARTNERSHIP IS ONE OF THEM AND I MENTIONED THE INTERNATIONAL PRO PRO PRO PROTOMICS THAT MET AND IT LOOKS AS THOUGH MORE COUNTRIES WILL BE SIGNING ON AND THEY MADE A DATA SHARING GLITCH TO SHARE INFORMING TO THE PUBLIC AND ADD ADVANCED CANCER CARE AND USING THE DATABASE PUBLICLY AVAILABLE A AND THERE WERE STUDIES OF ORAL CANCER. THERE'S THE THIRD CANCER TYPE FOR WHICH THERE'S NOT JUST PROTEIN LEVEL BUT ALSO POST TRANSLATIONAL INFORMATION AND THE OTHER ARE FROM THE U.S. OVARIAN CANCER AND BREAST CANCER AND IT WILL BE MUCH EASIER FOR US TO UNDERSTAND THROUGH THE STUDY OF THE PROTEO PROTEOMICS. IF YOU HAVEN'T GONE TO THE WEBSITE OR TRIED TO GET ACCESS IT'S SIMILAR FOR THE CANCER GENOME COMMONS. JIM HAD NOT PLANNED TO MAKE A PRESENTATION. I THINK HE'S SAVING HIS VOICE FOR CRITICAL THINGS BECAUSE HE HAS A EUROPEAN HOLD AND WE KNOW THEY ARE STRONG. ANYWAY, THANKS TO ALL OF YOU. >> QUESTIONS FOR DOUG OR FOR JIM? I GUESS WE'RE LETTING YOU OFF EASY HERE. >> IT'S TOO BAD BECAUSE WITH JIM HERE IF ANYONE ASKS A DIFFICULT QUESTION I CAN JUST REFER IT TO HIM. >> ALL RIGHT, WHEN WE LAST SAW YOU WE THANKED YOU FOR YOUR SERVICE AND EXCITED YOU'LL BE AT OUR TABLE FROM TIME TO TIME. THANKS SO MUCH. I THINK WE'RE COMING TO THE LAST PART OF OUR AGENDA WHICH HAS TO GO WITH ONGOING OR NEW BUSINESS. WE HAD HOPED TO RECOGNIZE OUR DEPARTING MEMBER DR. BLANEY BUT SHE'S DEPARTED. WE THANK HER. SHE'S BEEN SERVING FOR SOME TIME AS OUR PEDIATRIC REPRESENTATIVES AND APPRECIATE HER TIME. I'M SURE YOU'LL RECOGNIZE HER AT A DIFFERENT TIME. THE SECOND PART OF OUR AGENDA NOW IS TO TRY TO THINK ABOUT AT GOING FORWARD. TO BE LOOKING THIS IS OUR TIME TO HAVE OUR INPUT INTO THE AGENDA. I THINK SHEILA IS GOING TO HELP LEAD US THROUGH THAT DISCUSSION. >> SO IN THIS SECTION ALL I REALLY WANTED TO DO IS LET PEOPLE BE AWARE OF A COUPLE THINGS IN UPCOMING MEETINGS. THOSE WHO VOLUNTEERED TO HELP US IN THE FUTURE AGENDA ITEMS, WE WILL BE MEETING AT THE CONCLUSION OF THE MAIN MEETING. BUT I DID WANT TO MAKE SURE -- WE WERE ASKED TO HIGHLIGHT THIS RFI AND IT'S IMPORTANT FOR NCI TO REVIEW REQUEST FOR INFORMATION ON ENHANCING UTILIZATION OF THE NIH CRITICAL CENTER. YOU CAN SEE -- DELIN CAL CENTER. CLINICAL CENTER AND IT LOOKS FOR RESOURCES FOR THE NIH CLINICAL CENTER. I DON'T KNOW IF YOU HAVE ANY COMMENTS ON THIS AT ALL BUT I KNOW THIS IS AN OPPORTUNITY WHERE THEY'RE TRYING TO GATHER INFORMATION ON HOW NIH CAN BETTER UTILIZE -- >> THIS IS A NIH CLINICAL CENTER QUESTIONS. AS MEDICAL PRACTICES CHANGE OVERTIME THE CLINICAL CENTER IS A UNIQUE RESOURCE FOR IN-PATIENT TREATMENT AND WHETHER BECAUSE THERE'S NO ISSUES WITH THIRD-PARTY BILLING OR COMPLICATIONS WHEN YOU'RE DOING PATIENT INVESTIGATION ON THE OUTSIDE. THIS IS AN EXPLORATORY QUESTION IS THERE RESEARCH THE CLINICAL CENTER CAN ACCELERATE BY USING THE HOSPITAL BEDS. IT DOESN'T HAVE TO BE CANCER RESEARCH SO BRING IT BACK TO YOUR INSTITUTIONS BEYOND THAT. IT CAN BE METABOLIC TO MORE INTENSIVE IMMUNOTHERAPY WORK SO LOOK AT IT AND CIRCULATE IT. >> ONE OBVIOUS ONE IS A TYPE OF THERAPY. >> THERE'S A TWO-FOLD QUESTION. NUMBER ONE, IS THERE SOMETHING WE HAVEN'T THOUGHT OF YET AND ARE THERE PROGRAMS THAT ARE HARD TO DO AT THE LOCAL INSTITUTION WE CAN DO HERE AND CAN EXPAND MORE. MAYBE NOT EVEN WITH THE USE OF OUR OWN FACULTY HERE BUT FROM THE OUT SIDE IN PARTNERSHIP. SO THINK ABOUT THAT BECAUSE I THINK THERE'S INTEREST IN THAT. >> MAYBE YOU WANT TO TALK THE RARE CANCER INITIATIVE. >> AS PART OF THE MOONSHOT PROGRAM THERE'S FUNDING THROUGH OUR RARE CANCER INITIATIVE CHAIRED WITH MARK GILBERT IN NEUROONCOLOGY AND THE WORK IN PEDIATRIC TUMORS PUTTING TOGETHER A NATIONAL FOCUS ON PATIENTS WITH RARE TUMOR WHICH IS AN ATTEMPT TO BRING IN DATA FROM PATIENTS THROUGHOUT THE COUNTRY BRING IN PATIENTS AND FACULTY AS WELL AS TO FACILITATE TREATMENT. USING THE RESOURCES HERE TO ACCELERATE UNDERSTANDING OF RARE TUMORS. >> THAT THE STANDARD NCI DEFINITION OF RARE? >> I THINK THIS IS RARER RARE. >> OTHER COMMENTS OR QUESTIONS OR IDEAS OR IMPORTANT THINGS TO YOU? >> SO WE JUST LEARNED THERE'S A NEW DIRECTOR AT THE FREDERICK NATIONAL LABS, ETHAN DIMONTROSKI A FORMER CHAIR OF THE DOC, IT MAY GET BACK TO HOW TO OPTIMALLY LEVERAGE TO SUPPORT CLINICAL RESEARCH. >> NEW TOPIC? >> I DON'T RECALL IF THIS HAS BEEN ON AGENDA IN THE RECENT YEARS BUT THE QUANTITATIVE IMAGING NETWORK SYSTEM IS A SYSTEM THAT'S BEEN IN EFFECT A FEW YEARS. IT WOULD BE NICE TO SEE HOW THAT RELATES TO THE OVERALL NCI TRIAL ENTERPRISE. >> AGAIN, WE HAVE SEVERAL OTHER THINGS COMING UP WE'RE WORKING ON BUT WE'LL BE TALKING WITH THE GROUP HEMP US DO THAT. I DID AND ANYONE'S WELCOME AND WE'LL CONVENE A HALF OUR AFTER WE CONCLUDE. ORIGINALLY WE SAID 10:00 BUT A HALF HOUR AFTER THAT -- 1:00 BUT HALF OUR AFTER THAT. THE CONFERENCE ROOM SPACE IS UNDERGOING RENOVATION AND SO IT'S A MOVING TARGET BUT WE'VE BEEN TOLD TO DO. AND WHEN THEY RENOVATE WE'LL HAVE A NICER SPACE IN THE FUTURE BUT THERE'LL BE A PERIOD OF TIME WHERE WE'LL HAVE TO HOLD MEETINGS AT THE SHADY GROVE PAU CAMPUS. >> THE SAME PLACE AT THE HYATT IN BETHESDA BECAUSE -- >> WE WERE ORIGINALLY TOLD WE CAN'T HAVE THE MARCH MEETING. >> I DON'T KNOW THE DETAILS. >> OTHER UPDATES? >> NO. >> ALL RIGHT. ANY OTHER TOPICS. HEARING NONE I'LL SEE YOU MARCH 7 HERE IN BETHESDA FOR THE NEXT MEETING. MEETING JUNIORED.